Clinical trial NCT04162795
Conditions: Allergic Rhinitis
Keywords: Allergy Upper respiratory allergies
Sponsor: Bayer
Start date: 2019-11-12; Completion date: 2019-11-13
Enrollment: 468 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study, researchers were primarily interested in evaluating the level of agreement of cooling sensation provided by this chewable, flavored, allergy medicine. Participants joining this study received one test drug tablet and were asked to chew completely before swallowing the drug. A questionnaire was used to collect the feedback from participants. The study involved only one (1) visit and participant stayed in this study for about 60-75 minutes to evaluate the cooling sensation as well as other sensory attributes perceived in the mouth, nose and throat.

Detailed description:

Arms: arm 1: Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Interventions: intervention 1: Loratadine (Claritin, BAY76-2211)
Intervention descriptions: intervention 1: Chewable tablet, oral, single dose

Protocol documents:
Prot_SAP_000.pdf: 
 
Document Type: Study Protocol1 
Official Title: 
An open label, multi-center study to evaluate sensory attributes of 
an antihistamine product 
NCT Number: 
NCT04162795 
Document Date: 
21-OCT-2019 
 
 
 
1 Statistical Analysis Plan is not available for this sensory study. Statistical methods are mentioned in 
the Study Protocol. 


 
 
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1. 
TITLE PAGE 
Protocol Title: 
An open label, multi-center study to evaluate sensory attributes of an 
antihistamine product  
Protocol Number: 
Amendment Number: 
Compound Number: 
21048 
Not applicable 
BAY 762211 
 
Study Phase: 
4 
Sponsor Name: 
Legal Registered Address: 
Bayer HealthCare, LLC 
100 Bayer Boulevard 
Whippany NJ 07981-0915, USA 
 
 
 
 
Regulatory Agency Identifier Number(s):  Not applicable 
 
Approval Date: 21-Oct-2019 
 
 
Confidential 
The information provided in this document is strictly confidential and is intended solely for the 
performance of the clinical investigation.  Reproduction or disclosure of this document, whether in 
part or in full, to parties not associated with the clinical investigation or its use for any other purpose 
without the prior written consent of the sponsor is not permitted.  
Throughout this document, symbols indicating proprietary names (®, TM) may not be displayed. 
Hence, the appearance of product names without these symbols does not imply that these names are 
not protected. 
The study will be conducted in compliance with the protocol and any applicable regulatory 
requirements. 
 
 
 


PPD
PPD
PPD


 
 
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2. 
SYNOPSIS 
 
An open label, multi-center study to evaluate sensory attributes of an antihistamine product  
Primary Objective : 
• 
To evaluate perception of cooling sensation of a single dose of a flavored chewable 
antihistamine tablet 
The Test Product that will be tested is noted below.   
Product 
(UI # 1613932) 
Formula / Actuator Description Identifier   
BAY 762211 
Loratadine Chewable Tablet 
(10 mg) (Cool Mint) 
Drug substance 
Loratadine  
Excipients 
Anhydrous Citric Acid  
Aspartame  
Colloidal Silicon Dioxide  
FD&C Blue #1 Aluminum Lake  
Flavor, 
 
Flavor, 
 
Magnesium Stearate  
Mannitol  
Menthol  
Microcrystalline Cellulose  
Sodium Starch Glycolate  
Stearic Acid  
Comparator Products 
Not applicable    
Diagnosis and Main 
Criteria for Inclusion / 
Exclusion 
Main Inclusion Criteria: 
1. Capable of understanding and providing written informed 
consent and confidentiality including signatures. 
2. Female or male adults aged 18 to 65 years of age inclusive 
(recruitment to ensure that no less than approximately 40% 
of each gender is represented in the study population)  
3. Be in good general health 
4. Previous self-reported sufferers of upper respiratory allergies 
who at the time of the study are either asymptomatic, 
symptomatic but not treating and agree to use study 
medication or symptomatic and treating with an allergy 
medicine that is not an antihistamine 
CCI
CCI


 
 
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5. Agree to not use antihistamine products 24 hours before and 
after the treatment (see medication exclusion list, 
Appendix 1) 
6. Willing to comply with appropriate instructions provided to 
complete the study 
7. Willing to avoid eating food or candy (other than crackers 
consumed during testing), drinking any liquid other than 
water, gum chewing and teeth brushing one hour prior to 
testing 
8. Willing to follow and to adhere to the testing instructions as 
set forth in this protocol. 
Main Exclusion Criteria: 
Medication use  
1. Individuals who have used oral/systemic medications 24 
hours before the first administration of test product as listed 
in the medication exclusion, Appendix 1  
2. Individuals who use medications which may influence taste 
perception as listed in the medication exclusion, Appendix 
1 
3. Individuals who have received or used an investigational 
new drug in the last 30 days or have been an active 
participant in another clinical or market research study in the 
last 30 days.  
Medical conditions and history 
4. Women who are pregnant or thinking of becoming pregnant 
or are nursing. 
5. Participants with congestion at the time of study visit 
6. Any self-reported symptoms or conditions that may interfere 
with the participants ability to complete the evaluation of the 
product on testing day  
7. Any current medical condition that in the opinion of the 
Investigator or designee may interfere with normal taste 
and/or temperature perception (e.g., active common cold, 
sinus infection, bronchial infection, adenoids, paresthesia 
etc.) 
8. History of alcohol or drug abuse (self-reported) 
9. History of hypersensitivity or allergic reactions to any 
ingredients in the test product.  
10. Individuals with a history of glaucoma, liver or kidney 
disease, respiratory conditions such as chronic bronchitis or 
swallowing difficulties 


 
 
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11. Individuals who are currently wearing any kind of dental 
braces or with dental work or have cavities and associated 
pain that may affect their ability to chew a tablet 
Other exclusion criteria  
12. Currently working for a market research, flavor house, 
expert sensorial evaluator, or consumer product company; 
OR  Close affiliation with the investigational site; e.g. a 
close relative of the investigator, dependent person (e.g. 
employee or student of the investigational site) or Bayer 
employee or affiliate; OR They or someone else in the 
household work for a market research company, an 
advertising agency, a public relations firm, a pharmaceutical 
company, as a healthcare professional, or as part of a health 
care practice.  
Study Design 
This study is an open label, multi-center study assessing the cooling 
attribute of a flavored antihistamine chewable tablet. The study will 
consist of one site visit where a single dose (10 mg loratadine chewable 
tablet) of study product will be administered. 
Methodology 
Pre-Screening Phase (Electronic or Telephone pre-screening)   
The test site will recruit participants via an IRB approved screener. 
Potentially eligible participants will be given an appointment time to 
visit the site.  This Process will be 1 to 30 days prior to study start. 
Note: No recruiting will be performed unless IRB approval has been 
obtained.  
Screening Phase (On-site screening for verification of eligibility)   
• 
The study staff will screen potential participants to verify they 
meet the study’s eligibility criteria. Not all participants may fulfill 
the inclusion/exclusion criteria, so a higher number of 
participants than needed will be asked to participate in the 
screening examinations. 
• 
After obtaining the participant’s signature on the consent form, 
screening procedures will be performed and qualifying 
participants will be enrolled. 
• 
 If the screening procedures start on the same day the participant 
signs the informed consent form (ICF), the time of the 
participant’s signature must be recorded in the participant’s file 
Assessment Phase 
Adequate and appropriate training will be conducted to ensure 
participants understand the study tasks and how to use the study scales. 
A nurse practitioner will be on site during the entire dosing period.   
Visit 1, Day 1 (Assessment Phase) 
• 
One test product will be provided in a dosing cup to the 
participant and will be asked to chew completely before 
swallowing. Participants cannot drink water until end of visit. 
• 
Study staff initiates timer as soon as the study medication is 
administered 


 
 
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• 
Participant will be asked to indicate if he/she perceives a cooling 
sensation in each of the locations (mouth, nose and throat) at 10 
seconds, 30 seconds and 1 minutes post ingestion of study 
product 
• 
After the 1 minute time point, participants will be asked to 
complete a brief questionnaire on the sensory attributes of the test 
product. Participants will be allowed four (4) minutes to complete 
the questionnaire.   
• 
Following the completion of the questionnaire, participants will 
continue to evaluate perception of cooling sensation in the mouth, 
nose and throat  starting at the 5 minute time point and at 5 
minute intervals for 60 minutes  
• 
Following completion of all study assessments, participants will 
be asked open ended questions which will be used for learning 
purposes  
• 
The study visit will last approximately 60-75 minutes.  
• 
Adverse events, if applicable, will be recorded  
• 
Participants will be reminded to report any unusual or unexpected 
medical changes within the 24 hour period following 
administration of the study product to site personnel 
Follow Up Phase 
• 
At the End of Study, if a participant has an ongoing adverse 
event, the adverse event will be monitored and recorded and the 
participant will be contacted during the following week after 
discharge from the study site. 
Number of Participants 
Approximately 400 adults (100 per location: North East, South, Midwest 
and West regions within the United States of America)  
Primary Variable 
• 
Agreement (strongly agree or somewhat agree) of perception of 
cooling sensation based on a 5 point agreement scale 
Plan for Statistical Analysis Sensory attributes questionnaire: The percentage of selection of the 
top 2 choices (strongly agree and somewhat agree) will be determined 
for each question. This percentage and its 95% confidence interval will 
be calculated, if the lower bound of the confidence interval is greater 
than 50%, the statistical majority of agreement will be claimed. 
 
Time to perception of cooling and duration of cooling: variables will 
be analyzed descriptively (Mean, Standard deviation, Median, Mode and 
Range). The mean time point at which cooling is initially perceived will 
be claimed as the onset of cooling. The mean time point at which cooling 
is perceived to last will be claimed as the duration of cooling. 
Participants who never reach “Yes” in the perception of cooling will be 
(1) imputed by the maximum study time (60 minutes), and (2) treated as 
censored and used Kaplan-Meyer to estimate the median time to 
perception of cooling. 


 
 
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Table of Contents 
 
1. 
TITLE PAGE ..................................................................................................................... 1 
2. 
SYNOPSIS .......................................................................................................................... 3 
3. 
INTRODUCTION ........................................................................................................... 11 
4. 
STUDY OBJECTIVES .................................................................................................... 12 
5. 
STUDY DESIGN .............................................................................................................. 12 
5.1 
Design Overview .................................................................................................... 12 
5.2 
End of study Definition .......................................................................................... 12 
6. 
STUDY POPULATION .................................................................................................. 12 
6.1 
Inclusion Criteria .................................................................................................... 12 
6.2 
Exclusion Criteria .................................................................................................. 13 
6.3 
Lifestyle/Dietary Restrictions ................................................................................ 14 
6.4 
Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal
 ................................................................................................................................ 14 
6.4.1 
Screen Failures ......................................................................................... 14 
6.4.2 
Participant Discontinuation/Withdrawal from the Study ......................... 15 
6.4.3 
Lost to Follow Up .................................................................................... 15 
6.5 
Replacement ........................................................................................................... 15 
6.6 
Participant Identification ........................................................................................ 15 
7. 
TEST PRODUCTS .......................................................................................................... 16 
Test Products to be Administered/Tested .......................................................................... 16 
7.1 
Identity of Test Product .......................................................................................... 17 
7.2 
Test Product Assignment ....................................................................................... 17 
7.3 
Administration ....................................................................................................... 17 
7.4 
Blinding .................................................................................................................. 17 
7.5 
Test Product Logistics and Accountability ............................................................ 17 
7.6 
Test Product Compliance ....................................................................................... 18 
8. 
NON-STUDY THERAPY ............................................................................................... 19 
9. 
PROCEDURES AND VARIABLES .............................................................................. 20 
9.1 
Tabular Schedule of Evaluations ........................................................................... 20 
9.2 
Visit Description .................................................................................................... 21 
9.2.1 
Screening ................................................................................................. 21 
9.2.2 
Pre-dose (relative time: Day 1) ................................................................ 21 
9.2.3 
Randomization ......................................................................................... 22 
9.2.4 
Treatment ................................................................................................. 22 


 
 
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9.3 
Population Characteristics ...................................................................................... 22 
9.3.1 
Demographics .......................................................................................... 22 
9.3.2 
Medical History ....................................................................................... 23 
9.3.3 
Allergy Profile Questionnaire .................................................................. 24 
9.4 
Study Assessment .................................................................................................. 24 
9.4.1 
Cooling Time Point Assessment .............................................................. 24 
9.4.2 
Sensory Attributes Questionnaire ............................................................ 25 
9.4.3 
Open Ended Questions ............................................................................. 27 
9.5 
Adverse Events ...................................................................................................... 28 
9.5.1 
Definition if AE ....................................................................................... 28 
9.5.2 
Definition of SAE .................................................................................... 29 
9.5.3 
Recording and Follow-Up of AE and/or SAE ......................................... 30 
9.5.4 
Time Period and Frequency for Collecting AE and SAE Information .... 31 
9.5.5 
Follow-up of AEs and SAEs .................................................................... 32 
9.5.6 
Regulatory Reporting Requirements for SAEs ........................................ 32 
9.5.7 
Pregnancy ................................................................................................. 32 
9.5.8 
Disease-Related Events and/or Disease-Related Outcomes Not Qualifying 
as AEs or SAEs ........................................................................................ 33 
10. STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE ........... 34 
10.1 
General Considerations .......................................................................................... 34 
10.2 
Analysis Sets .......................................................................................................... 34 
10.3 
Variables and Planned Statistical Analyses ........................................................... 34 
10.4 
Determination of Sample Size ............................................................................... 34 
11. DATA HANDLING AND QUALITY ASSURANCE .................................................. 34 
11.1 
Data Recording ...................................................................................................... 34 
11.2 
Data Quality Assurance ......................................................................................... 35 
11.3 
Monitoring ............................................................................................................. 36 
11.4 
Data Processing ...................................................................................................... 36 
11.5 
Missing Data .......................................................................................................... 36 
11.6 
Audit and Inspection .............................................................................................. 36 
12. PREMATURE TERMINATION OF THE STUDY ..................................................... 37 
13. ETHICAL AND LEGAL ASPECTS ............................................................................. 38 
13.1 
Investigator(s) and Other Study Personnel ............................................................ 38 
13.2 
Funding .................................................................................................................. 38 
13.3 
Ethical and Legal Conduct of the Study ................................................................ 38 
13.4 
Participant Information and Consent ..................................................................... 39 
13.5 
Data Protection ....................................................................................................... 40 


 
 
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13.6 
Publication Policy .................................................................................................. 40 
13.7 
Compensation for Health Damage of Participants / Insurance .............................. 40 
14. APPENDIX:  MEDICATION EXCLUSION LIST ...................................................... 41 
15. REFERENCE LIST ......................................................................................................... 42 
 
 
 


 
 
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Table 1 
 List of Abbreviations 
 
AE 
Adverse Event 
CONSORT 
Consolidated Standards of Reporting Trials  
CRF 
Case Report Form 
CRO 
Contract Research Organization 
ICF 
Informed Consent Form 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
OTC 
Over the Counter 
SAE 
Serious Adverse Event 
SoA 
Schedule of Activities 
SP 
Study Protocol 
SUSAR 
suspected unexpected serious adverse reactions 
 
 


 
 
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3. 
INTRODUCTION 
Second generation antihistamines like loratadine are used for the temporary relief of symptoms 
associated with upper respiratory allergies.1 Several anti-histaminergic drugs are available as over-
the-counter (OTC) drugs around the world. In general, these medications are safe and effective 
when used as directed. Availability as OTC allows consumers to effectively manage their symptoms 
by following labeled instructions without needing to consult a health care provider.2 
In addition to efficacy benefits of an over-the-counter product, sensorial benefits may also be of 
importance for consumer acceptance.3 Bayer Consumer Health has a currently approved, flavored 
chewable tablet that contains the antihistamine, loratadine. Participants will be recruited to 
participate in this study that requires taking the product and evaluating sensory attributes of the 
product.  
 
 
 


 
 
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4. 
STUDY OBJECTIVES 
Primary Objective 
• To evaluate perception of cooling sensation of a single dose flavored chewable antihistamine 
tablet 
5. 
STUDY DESIGN 
5.1 
Design Overview 
This study is an open label (participants blinded to brand), multi-center study assessing the sensory 
attributes of a flavored antihistamine chewable tablet.  
 
The study will consist of one site visit where a single dose of study product will be administered. 
 
Approximately 520 subjects will be screened across 4 sites in the North East, South, Midwest and 
West regions within the United States of America. With approximately 400 adults completing; 100 
per location.   
 
Visit 1: participants will present for an onsite screening for inclusion and exclusion criteria prior to 
the beginning of any product evaluation. Upon qualification and prior to participation in the study, 
participants will sign an informed consent form.   
Qualifying participants will be instructed to chew completely before swallowing, one full dose (10 
mg loratadine chewable tablet) during this visit. The study visit will last approximately 60-75 minutes.  
 
A detailed description of study procedures and tabular schedule of evaluations will be found in Section 
9.  
 
5.2 
End of study Definition 
A participant is considered to have completed the study if he/she has completed all phases of the 
study including the last visit or the last scheduled procedure shown in the Schedule of Activities 
(SoA) (Section 9.1), including follow up if required. 
Primary completion 
The primary completion is defined as the date of completion of all assessments at visit 1.  
6. 
STUDY POPULATION 
6.1 
Inclusion Criteria 
Only participants who meet all of the following eligibility criteria will be eligible for the study: 
2. Female or male adults aged 18 to 65 years of age inclusive (recruitment to ensure that no 
less than approximately 40% of each gender is represented in the study population)  
1. Capable of understanding and providing written informed consent and confidentiality 
including signatures. 


 
 
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5.  Agree to not use antihistamine products 24 hours before and after the treatment (see 
medication exclusion list, Appendix 1) 
6. Willing to comply with appropriate instructions provided to complete the study 
7. Willing to avoid eating food or candy (other than crackers consumed during testing), 
drinking any liquid other than water, gum chewing and teeth brushing one hour prior to 
testing 
8. Willing to follow and to adhere to the testing instructions as set forth in this protocol. 
6.2 
Exclusion Criteria 
Participants presenting with any of the following will not be eligible for the study:  
Medication use  
1. Individuals who have used oral/systemic medication (prescription or non-prescription) 24 
hours before the first administration of test product, as listed in the medication exclusion 
Appendix 1.  
2. Individuals who use medications which may influence taste perception as listed in the 
medication exclusion, Appendix 1 
3. Individuals who have received or used an investigational new drug in the last 30 days or 
have been an active participant in another clinical or market research study in the last 30 
days.  
Medical conditions and history 
4. Women who are pregnant or thinking of becoming pregnant or are nursing. 
5. Participants with congestion at the time of study visit 
6. Any self-reported symptoms or conditions that may interfere with the participants ability 
to complete the evaluation of the product on testing day  
7. Any current medical condition that in the opinion of the Investigator or designee may 
interfere with normal taste and/or temperature perception (e.g., active common cold, 
sinus infection, bronchial infection, adenoids, paresthesia etc.) 
8. History of alcohol or drug abuse (self-reported) 
9. History of hypersensitivity or allergic reactions to any ingredients in the test product.  
10. Individuals with a history of glaucoma, liver or kidney disease, respiratory conditions 
such as chronic bronchitis or swallowing difficulties 
11. Individuals who are currently wearing any kind of dental braces or with dental work or 
have cavities and associated pain that may affect their ability to chew a tablet 
Other exclusion criteria  
12. Currently working for a market research, flavor house, expert sensorial evaluator, or 
consumer product company; OR  Close affiliation with the investigational site; e.g. a 
3. Be in good general health 
4. Previous sufferers of self-reported upper respiratory allergies who at the time of the study 
are either asymptomatic, symptomatic but not treating and agree to use study medication 
or symptomatic and treating with an allergy medicine that is not an antihistamine 


 
 
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close relative of the investigator, dependent person (e.g. employee or student of the 
investigational site) or Bayer employee or affiliate; OR They or someone else in the 
household work for a market research company, an advertising agency, a public relations 
firm, a pharmaceutical company, as a healthcare professional, or as part of a health care 
practice.  
 
Justification of selection criteria  
The selection criteria were chosen to ensure that participants with specific risks for administration of 
the study drug and/or participants with conditions that may have an impact on the aims of the study 
are excluded. 
 
6.3 
Lifestyle/Dietary Restrictions 
Participants will be restricted from eating food or candy (other than crackers consumed during 
testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to 
testing. During testing, participants cannot drink any liquid including water, chew gum or brush 
their teeth until the end of the visit; otherwise, there are no lifestyle restrictions.  
6.4 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal 
6.4.1 Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are not 
subsequently assigned to study intervention/entered in the study. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure participants to meet the 
Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to respond to 
queries from regulatory authorities. Minimal information includes demography, screen failure 
details, eligibility criteria, and any serious adverse event (SAE). 
A participant who, for any reason – e.g., failure to satisfy the selection criteria – terminates the study 
before the time point used for the definition of “dropout” is regarded a “screening failure”. A 
participant who discontinues study participation prematurely for any reason is defined as a 
“dropout” if the participant has already been administered at least one dose of the study medication. 
Individuals who do not meet the criteria for participation in this study (screen failure) may/may not 
be rescreened, with the following exceptions: 
• The participant had successfully passed the screening procedures, but could not start 
subsequent treatment on schedule. 
• Initial screening occurred too early to complete the required washout period after prior 
therapy. 
• The inclusion/exclusion criteria preventing the participant’s initial attempt to participate 
have been changed (via protocol amendment). 
In any case, the investigator has to ensure that the repeated screening procedures do not expose the 
participant to an unjustifiable health risk. Also, for re-screening, the participant has to re-sign the 


 
 
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informed consent form, even if it was not changed after the participant’s previous screening. 
Rescreened participants should be assigned a new participant number. 
6.4.2 Participant Discontinuation/Withdrawal from the Study 
• A participant may withdraw from the study at any time at his/her own request, or at the 
request of their legally acceptable representative, or may be withdrawn at any time at the 
discretion of the investigator for safety, behavioral, compliance, or administrative reasons. 
• A participant may be withdrawn from the study at the specific request of the sponsor and in 
liaison with the investigator (e.g. obvious non-compliance, safety concerns). 
• At the time of discontinuing from the study, if possible, an early discontinuation visit should 
be conducted, as shown in the Schedule of Activities (SoA). See SoA for data to be collected 
at the time of study discontinuation and follow-up and for any further evaluations that need 
to be completed. 
• The participant will be permanently discontinued both from the study intervention and from 
the study at that time. 
• If the participant withdraws consent for disclosure of future information, the sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
6.4.3 Lost to Follow Up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the study site.  
The following actions must be taken if a participant fails to return to the clinic for a required study 
visit: 
• The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible and counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the participant wishes to and/or should continue in the 
study. 
• Before a participant is deemed lost to follow up, the investigator or designee must make 
every effort to regain contact with the participant. These contact attempts should be 
documented in the participant’s medical record. 
• Should the participant continue to be unreachable, he/she will be considered lost to follow 
up. 
6.5 
Replacement 
Participants who drop out will be replaced by another participant who will qualify on inclusion and 
exclusion criteria. 
6.6 
Participant Identification 
Each participant is identified by the study site’s unique participant identification (SID) code. After 
informed consent/assent procedure every participant is given a screening number (SNR). Following 
assessment of inclusion and exclusion criteria, participants who meet the entry criteria will be 
sequentially assigned to a three-digit number in ascending order.  


 
 
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At the beginning of screening every participant is given a participant number (9 digit number 
consisting of: Digits 1 to 2  = Country code   (Code 14 is the U.S. country code) 
 
Digits 3 to 5 = Center number within the country (Code 001 for first center, 002 for second 
center and so on) 
 
Digits 1 to 5 = Trial unit   (For the first site, the center/trial number is 14001 which consists 
of the country code and the center number.) 
 
 
Digits 6 to 9 = Current patient/Participant number within the center (Participant numbers 
are the last four digits of the nine digit participant identification. First participant number at the 
first center is 160010001; second participant number is 160010002 and so on, which includes the 
country code, center number, and participant number. Participant numbers and screening numbers 
are the same number. 
 
7. 
TEST PRODUCTS 
Test Products to be Administered/Tested 
There is one test product to be administered/tested in this study: 
Table 2: Test Product 
Product 
(UI Number: 1613932) 
Strength 
Dosage Form or Quantity 
Route of 
Administration 
Loratadine Chewable Tablet 
10 mg 
1 Chewable Tablet* 
Oral  
*Each tablet to be chewed completely before swallowing. Participants are not allowed to drink 
water until the end of the visit  
Excipients (identification of potentially allergenic compounds may have to be considered) 
Anhydrous Citric Acid  
Aspartame  
Colloidal Silicon Dioxide  
FD&C Blue #1 Aluminum Lake  
Flavor, 
 
Flavor, 
 
Magnesium Stearate  
Mannitol  
Menthol  
Microcrystalline Cellulose  
Sodium Starch Glycolate  
Stearic Acid 
CCI
CCI


 
 
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7.1 
Identity of Test Product 
All test products will be labeled according to the requirements of local law and legislation.  Label 
text will be approved according to the sponsor’s agreed procedures, and a copy of the labels will be 
made available to the study site upon request. 
All study drugs will be stored at the investigational site in accordance with GCP and GMP 
requirements and the instructions given by the clinical supplies department of the sponsor (or its 
affiliate/CRO), and will be inaccessible to unauthorized personnel. Special storage conditions and a 
complete record of batch numbers and expiry dates can be found in the Sponsor’s study file; the site-
relevant elements of this information will be available in the investigator site file. On the day of 
receipt, the responsible site personnel will confirm receipt of study investigational products in 
writing. The personnel will use the study investigational products only within the framework of this 
clinical study and in accordance with this protocol. Receipt, distribution, return and destruction (if 
any) of the study drug must be properly documented according to the sponsor’s agreed and specified 
procedures. 
7.2 
Test Product Assignment 
The sample will be evaluated in a single monadic way (single product is rated by respondents), in a 
non-randomized fashion. The test produce to be evaluated will be blinded to the participants but not 
the site staff.  
7.3 
Administration 
Regarding amount, route / mode of administration, formulation(s) and duration of testing, refer to 
Section 7 
Each qualified participant will assess one (1) chewable tablet during each of his/her visit.  Each 
participant will be at the site for approximately 60-75 minutes.   
7.4 
Blinding 
As this is a single monadic study, the study will be performed in an open label design because the 
site technician will dispense the chewable tablets in dosing cups and then provide to test 
participants.  The participants will have a chance to visually inspect the product prior to 
administration and will be blinded to brand.  
7.5 
Test Product Logistics and Accountability 
All test products will be stored at the investigational site as per labeling requirements and the 
instructions given by the trial supplies department of the sponsor (or its affiliate/CRO), and will be 
inaccessible to unauthorized personnel.  On the day of receipt, the responsible site personnel will 
confirm receipt of test product in writing.  The personnel will use the test product only within the 
framework of this study and in accordance with this protocol.  Receipt, distribution, return and 
destruction (if any) of the test product must be properly documented according to the sponsor’s 
agreed and specified procedures. 


 
 
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7.6 
Test Product Compliance 
A member of the investigator’s team will monitor the administration of the study product. This 
person(s) will ascertain and document that the participant receives the test product as planned. 
 
 


 
 
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8. 
NON-STUDY THERAPY 
At the screening, potential participants will be asked questions from the health eligibility case report 
form (CRF) that verifies each participant meets the inclusion/exclusion criteria and qualifies for the 
study.  
Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, and/or 
herbal supplements) that the participant is receiving at the time of enrollment or receives during the 
study must be recorded along with: 
• Reason for use 
• Dates of administration including start and end dates 
• Dosage information including dose and frequency 
Participants should not use antihistamine products 24 hours before and after the treatment  


 
 
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9. 
PROCEDURES AND VARIABLES 
9.1 
Tabular Schedule of Evaluations 
 
 
 
 
Pre- Study 
(-30 Day to 
-1 Day) 
Visit 1 (Day 1) 
Baseline 
10 
s. 
30 
s. 
1 
min. 
(4 min 
interval) 
5 
min. 
10 
min. 
15 
min. 
…
* 
60 
min. 
End of 
Study 
and 
Follow-
up 
Pre-Screening 
X 
 
 
 
 
 
 
 
 
 
 
 
Informed 
Consent 
 
X 
 
 
 
 
 
 
 
 
 
 
Medical/Medicat
ion History 
 
X 
 
 
 
 
 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
 
 
 
 
 
Verification of 
Inclusion & 
Exclusion 
Criteria 
 
X 
 
 
 
 
 
 
 
 
 
 
Allergy Profile 
Questionnaire 
 
X 
 
 
 
 
 
 
 
 
 
 
Test Product 
Administration  
 
X 
 
 
 
 
 
 
 
 
 
 
Cooling Time 
Point 
Assessment 
 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
 
Sensory 
Attributes 
Questionnaire 
 
 
 
 
 
X 
 
 
 
 
 
 
Open Ended 
Questions 
 
 
 
 
 
 
 
 
 
 
 
X 
Adverse Event 
Monitoring 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Xǂ 
(…)* Time points are at 5-minute intervals up to the last time point.  
ǂAt the End of Study, if a participant has an ongoing adverse event, the adverse event will be monitored and recorded and the 
participant will be contacted during the following week after discharge from the study site. 


 
 
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s= seconds, min= minutes 
 
9.2 
Visit Description 
9.2.1 Screening   
Pre-Screening Phase 
In this study, the test site will recruit participants via an IRB approved screener. Potentially eligible 
participants will be given an appointment time to visit the site.  This process will be 1 to 30 days 
prior to study start. 
Screening Phase 
Note: No screening procedures may be performed unless written informed consent has been 
obtained. During the screening period, the study staff will screen potential participants to verify 
they meet the study’s eligibility criteria. Not all participants may fulfill the inclusion / exclusion 
criteria, so a higher number of participants than needed will be asked to participate in the screening 
examinations. If the (first) screening procedures start on the same day the participant signs the 
informed consent form/assent (ICF), the time of the participant’s signature must be recorded in the 
participant’s file. 
After obtaining the participant’s signature on the consent form, the below listed screening 
procedures will be performed and the respective results will be assessed on the day of the first study 
drug administration: 
• allocation of participant identification (see Section 6.6) 
• demographic data 
• review eligibility  
• questioning for special behavior (e.g., eating food or candy, chewing gum, or brushing teeth 
within one (1) hour prior to enrollment on testing day and not willing to abstain from this at least 
1 hour prior to testing)  
• participation in previous research studies 
No participant will be assigned a participant number unless adherence to all selection criteria as 
given in Section 6.1 and Section 6.2 is established. 
9.2.2 Pre-dose (relative time: Day 1) 
Participants will arrive at the study site for their scheduled study visit at the designated time 
preceding study drug administration. The following measures / actions will be carried out: 
• Informed consent 
• Review of inclusion- / exclusion criteria 
• Allergy Profile Questionnaire  


 
 
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9.2.3 Randomization 
No randomization schedule will be used.  
9.2.4 Treatment  
Treatment / Assessment Phase 
Prior to each assessment, adequate and appropriate training will be conducted to ensure participants 
understand the task and how to use the study scales. An appropriate nurse practitioner will be on site 
during the entire dosing period.   
 
Visit 1 (Day 1)  
• One test product will be provided in a dosing cup to each participant who will then be asked 
to completely chew completely before swallowing. Participants cannot drink water until end 
of visit. 
• Study staff initiates timer as soon as the study medication is administered 
• Participant will be asked to indicate on the case report form (CRF) if he/she perceives a 
cooling sensation in the mouth, nose and throat at 10 seconds, 30 seconds and 1 minutes post 
ingestion of test product 
• After the 1-minute time point, participants will be asked to complete a brief questionnaire on 
the sensory attributes of the test product. Participants will be allowed four (4) minutes to 
complete the questionnaire.   
• Following the completion of the questionnaire, participants will continue to evaluate 
perception of cooling sensation in the mouth, nose and throat at 5 minute intervals, starting at 
the 5 minute time point for 60 minutes  
• Following completion of all study assessments, participants will be asked open ended 
questions which will be used for learning purposes  
• Adverse events, if applicable, will be recorded  
• Participants will be reminded to report any unusual or unexpected medical changes within the 
24 hour period following administration of the study medication to site personnel 
 
Follow- Up 
At the End of Visit 1, if a participant has an ongoing adverse event, he/she will be contacted during 
the following week after discharge from the study site. 
 
9.3 
Population Characteristics 
9.3.1 Demographics 
The following information will be collected for the Demographics 
• Year of birth 
• Sex 


 
 
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• Race/ethnicity   
 
9.3.2 Medical History 
Medical history findings (i.e. previous diagnoses, diseases or surgeries) meeting all criteria listed 
below will be collected as available to the investigator: 
• Start before signing of the informed consent  
• Considered relevant for the participant’s study eligibility. 


 
 
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Detailed instructions on the differentiation between (i) medical history and (ii) adverse events can be 
found in Section 9.5.1. 
9.3.3 Allergy Profile Questionnaire 
The following questionnaire will be completed by subjects prior to dosing.  
Allergy Profile Questionnaire 
1. What type of allergies have you experienced in the last 12 months? (Select all that apply) 
a. Seasonal allergies 
b. Dust or dust mite allergies 
c. Pet/ animal allergies 
d. Mold  
e. Other __________ 
2. 
 
 
 
 
 
 
 
 
3. 
 
 
 
9.4 
Study Assessment 
The following study specific assessments will be performed by the participants during this study. 
9.4.1 Cooling Time Point Assessment  
Participants will be instructed to complete as follows: 
“Please indicate at each time point whether you perceive a cooling sensation in the mouth (1), nose 
(2), throat (3) or (4) No Sensation Felt.  
CCI
CCI


 
 
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Time 
Cooling in the 
mouth 
(1) 
Cooling in the 
nose 
(2) 
Cooling in the  
throat 
(3) 
No Sensation 
Felt 
 (4) 
Immediate 
(10 seconds) 
 
 
 
 
30 seconds 
 
 
 
 
1 minute  
 
 
 
 
Complete the sensory attributes questionnaire  
(see questionnaire below) 
 
5 minutes 
 
 
 
 
10 minutes 
 
 
 
 
15 minutes  
 
 
 
 
20 minutes 
 
 
 
 
25 minutes 
 
 
 
 
30 minutes  
 
 
 
 
35 minutes  
 
 
 
 
40 minutes 
 
 
 
 
45 minutes  
 
 
 
 
50 minutes 
 
 
 
 
55 minutes 
 
 
 
 
60 minutes 
 
 
 
 
 
9.4.2  Sensory Attributes Questionnaire  
Participants will be instructed to complete the questionnaire as following: 
“Please indicate to what level you agree or disagree with the corresponding statement:”  


 
 
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Question 
Strongly 
agree (5) 
Somewhat 
agree (4) 
Neither 
agree nor 
disagree 
(3) 
Somewhat 
disagree 
(2) 
Strongly 
disagree (1) 
The product provides a 
cooling sensation 
 
 
 
 
 
The product provides a 
cooling sensation in the 
mouth 
 
 
 
 
 
The product provides a 
cooling sensation in the 
nose 
 
 
 
 
 
The product provides a 
cooling sensation in the 
throat 
 
 
 
 
 
The product provides a 
refreshing sensation 
 
 
 
 
 
The product provides a 
refreshing sensation in the 
mouth 
 
 
 
 
 
The product provides a 
refreshing sensation in the 
nose 
 
 
 
 
 
The product provides a 
refreshing sensation in the 
throat 
 
 
 
 
 
The product tastes great 
 
 
 
 
 
The product experience was 
enjoyable 
 
 
 
 
 


 
 
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9.4.3 
 
 
 
 
 
 
 
I like the flavor sensation of 
the product  
 
 
 
 
 
The product feels soothing 
on the throat 
 
 
 
 
 
The sensory experience is 
unique for an allergy 
medicine 
 
 
 
 
 
The cooling sensation is 
refreshing 
 
 
 
 
 
CCI


 
 
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9.5 
Adverse Events 
9.5.1 Definition if AE 
AE Definition 
• An AE is any untoward medical occurrence in a patient or clinical study participant, 
associated with the use of study intervention, whether or not considered related to 
the study intervention. 
• NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) associated 
with the use of study intervention. 
 
Events Meeting the AE Definition  
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) 
or other safety assessments (eg, ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator. 
• Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should be reported regardless of sequelae. 
• The signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will be 
reported as AE or SAE if they fulfil the definition of an AE or SAE. Also, “lack of 
efficacy” or “failure of expected pharmacological action” also constitutes an AE or 
SAE. 
 
Events NOT Meeting the AE Definition  
• Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition. 
• The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition. 


 
 
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• Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present 
or detected at the start of the study that do not worsen. 
9.5.2 
Definition of SAE 
An SAE is defined as any untoward medical occurrence that, at any dose: 
a. 
Results in death 
b. 
Is life-threatening 
• The term 'life-threatening' in the definition of 'serious' refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event, 
which hypothetically might have caused death, if it were more severe. 
c. 
Requires inpatient hospitalization or prolongation of existing hospitalization 
• In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the physician’s 
office or outpatient setting. Complications that occur during hospitalization are AEs. 
If a complication prolongs hospitalization or fulfills any other serious criteria, the 
event is serious. When in doubt as to whether “hospitalization” occurred or was 
necessary, the AE should be considered serious. 
• Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline is not considered an AE. 
d. 
Results in persistent disability/incapacity 
• The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
• This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, 
and accidental trauma (eg, sprained ankle) which may interfere with or prevent 
everyday life functions but do not constitute a substantial disruption. 
e. 
Is a congenital anomaly/birth defect 
f. 
Other situations: 
• Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that 
may not be immediately life-threatening or result in death or hospitalization but may 
jeopardize the participant or may require medical or surgical intervention to prevent 
one of the other outcomes listed in the above definition. These events should usually 
be considered serious. 


 
 
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• Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug dependency 
or drug abuse. 
9.5.3 
Recording and Follow-Up of AE and/or SAE  
AE and SAE Recording 
• When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostics 
reports) related to the event. 
• The investigator will then record all relevant AE/SAE information in the CRF. 
• It is not acceptable for the investigator to send photocopies of the participant’s 
medical records in lieu of completion of the AE/SAE CRF page. 
• There may be instances when copies of medical records for certain cases are 
requested. In this case, all participant identifiers, with the exception of the 
participant number, will be redacted on the copies of the medical records before 
submission. 
• The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not 
the individual signs/symptoms) will be documented as the AE/SAE. 
Assessment of Intensity 
• The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the following categories:  
• Mild: An event that is easily tolerated by the participant, causing minimal 
discomfort and not interfering with everyday activities. 
• Moderate: An event that causes sufficient discomfort and interferes with normal 
everyday activities. 
• Severe: An event that prevents normal everyday activities. An AE that is assessed as 
severe should not be confused with an SAE. Severe is a category utilized for rating 
the intensity of an event; and both AEs and SAEs can be assessed as severe. 
• An event is defined as ‘serious’ when it meets at least 1 of the predefined outcomes 
as described in the definition of an SAE, NOT when it is rated as severe. 
 


 
 
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Assessment of Causality 
• The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE. 
• A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out. 
• The investigator will use clinical judgment to determine the relationship. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated. 
• The investigator will also consult the Investigator’s Brochure (IB) and/or Product 
Information, for marketed products, in his/her assessment. 
• For each AE/SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE/SAE and has provided an assessment of causality. 
• There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to. However, it is very 
important that the investigator always make an assessment of causality for 
every event before the initial transmission of the SAE data. 
• The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality 
assessment. 
• The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
Follow-up of AEs and SAEs 
• The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested to elucidate 
the nature and/or causality of the AE or SAE as fully as possible. This may include 
additional laboratory tests or investigations, histopathological examinations, or 
consultation with other health care professionals. 
• New or updated information will be recorded in the originally completed CRF. 
• The investigator will submit any updated SAE data to sponsor contact within 24 
hours of receipt of the information. 
 
9.5.4 
Time Period and Frequency for Collecting AE and SAE Information  
All SAEs will be collected from the signing of the informed consent form (ICF) OR until the follow-
up visit at the time points specified in the SoA. 
All AE will be collected from the signing of the ICF until at the time points specified in the SoA . 


 
 
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Medical occurrences that begin before the start of study intervention but after obtaining informed 
consent will be recorded on the Medical History/Current Medical Conditions section of the case 
report form (CRF) not the AE section. 
All SAEs will be recorded and reported to the sponsor or designee immediately and under no 
circumstances should this exceed 24 hours. The investigator will submit any updated SAE data to 
the sponsor within 24 hours of it being available. 
Investigators are not obligated to actively seek AE or SAE after conclusion of the study 
participation. However, if the investigator learns of any SAE, including a death, at any time after a 
participant has been discharged from the study, and he/she considers the event to be reasonably 
related to the study intervention or study participation, the investigator must promptly notify the 
sponsor.  
9.5.5 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow each participant at 
subsequent visits/contacts. All SAEs, and non-serious AEs will be followed until resolution, 
stabilization, the event is otherwise explained, or the participant is lost to follow-up.  
9.5.6 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a 
study intervention under clinical investigation are met. See section 9.5.4 for reporting time 
periods. Investigator should notify the sponsor by sending the completed SAE forms to: 
 
 or Fax: 
 
 
• The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, Institutional Review Boards (IRB)/Independent Ethics 
Committees (IEC), and investigators, as applicable. 
• Investigator safety reports must be prepared for suspected unexpected serious adverse 
reactions (SUSAR) according to local regulatory requirements and sponsor policy and 
forwarded to investigators as necessary. 
• An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAEs) from the sponsor will review 
and then file it along with the Investigational Product information and will notify the 
IRB/IEC, if appropriate according to local requirements. 
9.5.7 
Pregnancy 
The investigator must report to the sponsor any pregnancy occurring in a female study participant 
during her participation in this study.  The outcome of the pregnancy should be followed up 
carefully, and any outcome of the mother and the child at delivery should be reported. 
PPD
PPD


 
 
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For all reports, the forms provided are to be used.  The investigator should submit them within the 
same timelines as an SAE. Send the completed SAE forms to: 
 or Fax: 
 
 
9.5.8 
Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as 
AEs or SAEs 
The following events are common in participants with upper respiratory allergies  
• Runny nose 
• Sneezing 
• Itchy, watery eyes 
• Itching of the nose or throat 
• Nasal congestion  
Although the study drug contains an active ingredient approved for all the above listed symptoms 
(except nasal congestion), onset of relief of symptoms may or may not be achieved prior to the 
conclusion of the study assessment.  Given that this study is not designed to assess efficacy and 
because these events are typically associated with the condition under study, they do not qualify as 
an AE.  
 
 
PPD
PPD


 
 
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10. 
STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE 
10.1 
General Considerations 
All statistical analyses will be conducted using SAS. Missing data will not be imputed. 
10.2 
Analysis Sets 
All participants who have an evaluation data for study medication will be included into the statistical 
analysis of the primary parameter.  
 
Safety Population 
Any participant who receives the study medication will be included for the analyses of adverse 
events. 
10.3 
Variables and Planned Statistical Analyses 
Variables 
Primary Variable 
• Agreement (strongly agree or somewhat agree) of perception of cooling sensation based on a 
5 point agreement scale 
Adverse events will be collected and assessed by the investigator. 
Statistical and Analytical Plans 
Questionnaire: The primary variable of interest will be analyzed by determining the percentage of 
selection of the top 2 choices (strongly agree and somewhat agree). This percentage and its 95% 
confidence interval will be calculated, if the lower bound of the confidence interval is greater than 
50%, the statistical majority of agreement will be claimed. Other secondary variables of interests 
from the questionnaire will be analyzed in the same manner as the primary variable.   
Time to perception of cooling and duration of cooling: These secondary variables will be 
analyzed descriptively (Mean, Standard deviation, Median, Mode and Range). The mean time point 
at which cooling is initially perceived will be claimed as the onset of cooling. The mean time point 
at which cooling is perceived to last will be claimed as the duration of cooling.  
Participants who never reach “Yes” in the perception of cooling will be (1) imputed by the 
maximum study time (60 minutes), and (2) treated as censored and used Kaplan-Meyer to estimate 
the median time to perception of cooling. 
10.4 
Determination of Sample Size 
The sample size of 400 participants was based on accepted industry standards for sensory studies.  
11. 
DATA HANDLING AND QUALITY ASSURANCE 
11.1 
Data Recording 
The data collection tool for this study will be questionnaires.   


 
 
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Source Documentation 
The site must implement processes to ensure availability of all required source documentation.   
It is the expectation of the sponsor that all data entered into the CRF has source documentation 
available at the site.   
It is the expectation of the sponsor that all data entered into the CRF has source documentation 
available at the site except for the data listed below which will be entered directly into the CRF; 
thus, these CRF data will be the source and no additional source documentation will be available.   
11.2 
Data Quality Assurance 
• The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents.  
• The sponsor or designee is responsible for the data management of this study including 
quality checking of the data.  
• The sponsor assumes accountability for actions delegated to other individuals (eg, CROs). 
• Study monitors may perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, and all applicable regulatory requirements.  
• Records and documents, including signed ICFs, pertaining to the conduct of this study must 
be retained by the investigator for 10 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor.  


 
 
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11.3 
Monitoring 
In accordance with applicable regulations, and sponsor’s/CRO’s procedures, monitors will contact 
the site prior to the start of the study to review with the site staff the protocol, study requirements, 
and their responsibilities to satisfy regulatory, ethical, and sponsor’s requirements.  When reviewing 
data collection procedures, the discussion will also include identification and documentation of 
source data items. 
The sponsor/designee will monitor the site activity to verify that the: 
• Data are authentic, accurate and complete.   
Supporting data may be requested (example: blood glucose readings to support a diagnosis of 
diabetes).  
• Safety and rights of participants are being protected 
• Study is conducted in accordance with the currently approved protocol  
(including test product being used in accordance with the protocol) 
• Any other study agreements and all applicable regulatory requirements are met. 
The investigator and the head of the medical institution (where applicable) agrees to allow the 
monitor direct access to all relevant documents. 
11.4 
Data Processing 
Data will be collected as described in Section 11.1.  Data management will be performed in 
accordance with applicable sponsor’s/CRO’s standards and data cleaning procedures.   
As applicable for data coding (e.g. AEs, medication), internationally recognized and accepted 
dictionaries will be used. 
11.5 
Missing Data  
Any missing data will be left as such. 
11.6 
Audit and Inspection 
To ensure compliance with regulatory requirements, a member of the sponsor’s (or a designated 
CRO’s) quality assurance unit may arrange to conduct an audit to assess the performance of the 
study at the study site and of the study documents originating there.  The investigator/institution will 
be informed of the audit outcome. 
In addition, inspections by regulatory health authority representatives and IEC(s)/IRB(s) are 
possible.  The investigator should notify the sponsor immediately of any such inspection. 
The investigator/institution agrees to allow the auditor or inspector direct access to all relevant 
documents and allocate his/her time and the time of his/her staff to the auditor/inspector to discuss 
findings and any issues.  Audits and inspections may occur at any time during or after completion of 
the study. 
 


 
 
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12. 
PREMATURE TERMINATION OF THE STUDY 
The sponsor has the right to close this study at any time.  The investigator has the right to close 
his/her center at any time. 
If the study is to be closed for any reason, the following applies: 
• Closures should occur only after consultation between involved parties.  Final decision on the 
closure must be in writing. 
• All affected institutions (e.g. IEC(s)/IRB(s); competent authority(ies); study center; head of 
study center) must be informed as applicable according to local law. 
• All study materials (except documentation that has to remain stored at site) must be returned 
to the sponsor.  The investigator will retain all other documents until notification is given by 
the sponsor for destruction. 
• In the event of a partial study closure, ongoing participants, including those in post study 
follow-up, must be taken care of in an ethical manner. 
Details for individual participant's withdrawal can be found in Section 6.4.2  
 
 


 
 
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13. 
ETHICAL AND LEGAL ASPECTS 
13.1 
Investigator(s) and Other Study Personnel 
Sponsor’s Study Medical Expert 
 
  
Bayer HealthCare Consumer Care 
100 Bayer Boulevard 
Whippany, NJ  07981 
Email: 
 
Phone: 
 
 
 
  
Bayer HealthCare Consumer Care 
100 Bayer Boulevard 
Whippany, NJ  07981 
Email: 
 
Phone: 
 
 
All other study personnel not included in this section are identified in a separate personnel list (not 
part of this study protocol) as appropriate.  This list will be updated as needed; an abbreviated 
version with personnel relevant for the centers will be available in each center’s investigator site 
file. 
Whenever the term ‘investigator’ is noted in the protocol text, it may refer to either the principal 
investigator at the site, or an appropriately qualified, trained and delegated individual of the 
investigational site. 
The principal investigator of each center must sign the protocol signature page and must receive all 
required external approvals (e.g. health authority, ethics committee, sponsor) before participant 
recruitment may start at the respective center.  Likewise, all amendments to the protocol must be 
signed by the principal investigator and must have received all required external approvals before 
coming into effect at the respective center. 
13.2 
Funding  
Funding 
This study will be funded by its sponsor. 
13.3 
Ethical and Legal Conduct of the Study 
The procedures set out in this protocol, pertaining to the conduct, evaluation, and documentation of 
this study, are designed to ensure that the sponsor and investigator abide by: 
PPD
PPD
PPD
PPD
PPD
PPD


 
 
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• The guiding principles detailed in the Declaration of Helsinki and Council for International 
Organizations of Medical Sciences (CIOMS) International Ethical Guidelines,    
• Applicable ICH Good Clinical Practice (GCP) Guidelines  
• Applicable local law(s) and regulation(s). 
Strict adherence to all specifications laid down in this protocol is required for all aspects of study 
conduct; the investigator may not modify or alter the procedures described in this protocol.   
Modifications to the study protocol will not be implemented by either the sponsor or the investigator 
without agreement by both parties.  Any deviations from the protocol must be explained and 
documented by the investigator.  
The protocol, protocol amendments, ICF, and other relevant documents (e.g., advertisements) must 
be submitted to an IRB/IEC by the investigator and reviewed and approved by the IRB/IEC before 
the study is initiated.  
Any amendments to the protocol will require IRB/IEC approval before implementation of changes 
made to the study design, except for changes necessary to eliminate an immediate hazard to study 
participants.  
The investigator will be responsible for the following: 
o Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC. 
o Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures. 
o Providing oversight of the conduct of the study at the site and adherence to 
requirements of ICH guidelines, the IRB/IEC and all other applicable local 
regulations. 
 
Details on discontinuation of the entire study or parts thereof can be found in Section 0. 
13.4 
Participant Information and Consent 
• The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions regarding the 
study.  
• Participants must be informed that their participation is voluntary. Participants or their 
legally authorized representative will be required to sign a statement of informed consent 
that meets the requirements of 21 CFR 50, local regulations, ICH guidelines, Health 
Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and 
the IRB/IEC or study center.  


 
 
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• The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICF. 
• Participants must be re-consented to the most current version of the ICF(s) during their 
participation in the study.  
• A copy of the ICF(s) must be provided to the participant or the participant’s legally 
authorized representative. . 
Participants who are rescreened are required to sign a new ICF. 
13.5 
Data Protection 
• Participants will be assigned a unique identifier. Any participant records or datasets that are 
transferred to the sponsor will contain the identifier only; participant names or any 
information which would make the participant identifiable will not be transferred.  
• The participant must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.  
• The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/IEC members, and by inspectors from regulatory authorities. 
13.6 
Publication Policy 
• The results of this study may be published or presented at scientific meetings. If this is 
foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor before 
submission. This allows the sponsor to protect proprietary information and to provide 
comments.  
• The sponsor will comply with the requirements for publication of study results. In 
accordance with standard editorial and ethical practice, the sponsor will generally support 
publication of multicenter studies only in their entirety and not as individual site data. In this 
case, a coordinating investigator will be designated by mutual agreement. 
• Authorship will be determined by mutual agreement and in line with International 
Committee of Medical Journal Editors authorship requirements.   
13.7 
Compensation for Health Damage of Participants / Insurance 
The sponsor maintains product liability insurance, if required, for this study in accordance with the 
laws and regulations of the country in which the study is performed. 


 
 
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14. 
APPENDIX:  MEDICATION EXCLUSION LIST 
 
Individuals who have used the following medications 24 hours before the first administration of test 
product should be excluded 
 
• 
Amiodarone (Cordarone, Pacerone) 
• 
Carbamazepine (Tegretol, Tegretol-XR, Epitol, Equetro)  
• 
Cimetidine (Tagamet)  
• 
Ketoconazole (Nizoral)  
• 
Pitolisant (Wakix) 
• 
Potassium Citrate (Urocit-K) 
 
To be included in the study, subjects must agree not to use any antihistamine products 24 hours 
before and after treatment. The following are examples of commonly used antihistamine containing 
products:  
 
Single ingredient oral antihistamine medications 
• 
Diphenhydramine (Benadryl, Benadryl Allergy) 
• 
Chlorpheniramine (Chlor-Trimeton) 
• 
Doxylamine (Unisom) 
• 
Cetirizine (Zyrtec) 
• 
Fexofenadine (Allegra Allergy) 
• 
Loratadine (Claritin, Alavert) 
• 
Levocetirizine (Xyzal) 
• 
Clemastine (Tavist Allergy) 
 
Antihistamine containing oral combination medications 
• 
Chlorpheniramine/pseudoephedrine  
• 
Loratadine/pseudoephedrine (Claritin D) 
• 
Cetirizine/pseudoephedrine (Zyrtec D) 
• 
Fexofenadine/pseudoephedrine (Allegra D) 
 
Antihistamine nasal sprays  
• Azelastine (Astelin, Astepro) 
• Olapatadine (Patanase) 
 
Antihistamine containing oral cough and cold combination medications 
 
• Note: Several cough and cold combination medications are available on the market, some, 
which contain antihistamines, and some, which do not. A review of the Drug Facts Label will 
be required to determine which products contains an antihistamine. 
 


 
 
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Individuals who use any of the following medications which may influence taste perception are 
excluded from the study: 
 
• 
Acetazolamide (Diamox Sequels) 
• 
Cisplatin (Platinol-AQ) 
• 
Eszopiclone (Lunesta) 
• 
Topiramate (Topamax, Topiragen, Trokendi XR, Quedexy XR) 
• 
Captopril (Capoten) 
• 
Lithium (Eskalith, Eskalith-CR, Lithobid)  
• 
Procainamide (Procanbid, Pronestyl, Pronestyl-SR) 
• 
Terbenafine (Lamisil, Lamisil AT, Terbinex) 
• 
Amiodarone (Cordarone, Pacerone)  
 
 
15. 
REFERENCE LIST  
1. Sur DK, Plesa ML. Treatment of Allergic Rhinitis. Am Fam Physician. 2015 Dec 
1;92(11):985-92 
2. U.S. Food and Drug Administration. Prescription and Over-the-Counter (OTC): Questions 
and Answers. Retrieved from : https://www.fda.gov/drugs/questions-answers/prescription-
drugs-and-over-counter-otc-drugs-questions-and-answers  
3. Liu, Fang et al. “Patient-centred pharmaceutical design to improve acceptability of 
medicines: similarities and differences in paediatric and geriatric populations.” Drugs vol. 
74,16 (2014): 1871-1889.