Clinical trial NCT02641912: Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms
Official title: A Clinical Study to Evaluate the Efficacy of an Experimental Mouthwash Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-12-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a single center, 7-day, examiner blind, two treatment-arm, randomized, stratified (Sjogren's Syndrome status \[Y/N\]), parallel group study conducted in participants experiencing dry mouth symptoms. This study is designed to investigate the effect of an experimental mouthwash formulation in providing relief of dry mouth symptoms.


Eligibility criteria: Inclusion Criteria:

* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
* Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination
* Subject with stable and controlled condition with no overt medical conditions which would contraindicate participation (in the opinion of the Investigator or medically qualified designee) and no clinically significant and relevant abnormalities of medical history or oral examination which would interfere with the conduct of the study
* All subjects should report having a feeling of a dry mouth according to the DMSQ. (Subject must answer at least 2 out of the 4 questions with 'agree a little', 'agree' or 'strongly agree'
* Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit
* Previous participation in this study
* Recent history (within the last 1 year) of alcohol or other substance abuse
* An employee of the sponsor or the study site or members of their immediate family
* Subjects with Sjögren's Syndrome along with reporting having a feeling of dry mouth according to the DMSQ, should also have a confirmed diagnosis of their condition as shown by a positive salivary gland biopsy or SS-A (anti-Ro antibody) or SS-B (La antibody) or a letter from a physician if diagnosis was made more than 3 years ago OR Subjects reporting having a feeling of dry mouth due to other diseases or conditions excluding Sjögren's Syndrome
* Understands and is willing, able and likely to comply with all study procedures and restrictions.

Exclusion Criteria:

* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
* Women who are breast-feeding
* Subject is currently undergoing radiotherapy and/or chemotherapy treatment
* Any condition the investigator identifies that can confound the subject's ability to properly participate in the study e.g. Alzheimer's Disease
* Subjects with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration)
* Evidence of gross intra-oral neglect or need for extensive dental therapy

  -. Denture wearer (complete dentures)
* Subjects not on stable doses of prescription systemic parasympathetic medications (e.g. Pilocarpine), for the treatment of the feeling of dry mouth
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
* Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit
* Previous participation in this study
* Recent history (within the last 1 year) of alcohol or other substance abuse
* An employee of the sponsor or the study site or members of their immediate family

Primary outcomes:
measure: Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in Product Performance and Attributes Questionnaire 3 (PPAQ3) at 120 Minutes(Mins) Post Treatment on Day 8
timeFrame: 120 mins post treatment on Day 8
Secondary outcomes:
measure: Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in Product Performance And Attributes Questionnaire 2 (PPAQ2) at 30 Mins Post Treatment on Day 8
timeFrame: 30 mins post treatment on Day 8
measure: Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8
timeFrame: 60 and 240 mins post treatment on Day 8
measure: Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8
timeFrame: 5 mins post treatment on Day 8
measure: Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8
timeFrame: 30 mins post treatment on Day 8
measure: Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8
timeFrame: 60 mins. post treatment on Day 8
measure: Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8
timeFrame: 120 mins. post treatment on Day 8
measure: Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8
timeFrame: 240 mins. post treatment on Day 8
measure: Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8
timeFrame: prior to treatment on Day 8
measure: Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1
timeFrame: 5 mins post treatment on Day 1
measure: Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1
timeFrame: 30 mins post treatment on Day 1
measure: Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1
timeFrame: 60 mins post treatment on Day 1
measure: Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1
timeFrame: 120 mins post treatment on Day 1
measure: Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1
timeFrame: 240 mins post treatment on Day 1
measure: Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3
timeFrame: 5 mins post treatment on Day 3
measure: Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3
timeFrame: 30 mins post treatment on Day 3
measure: Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3
timeFrame: 60 mins. post treatment on Day 3
measure: Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3
timeFrame: 120 mins post treatment on Day 3
measure: Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3
timeFrame: 240 mins post treatment on Day 3
measure: Mean Response to PPAQ4 Prior to Treatment on Day 3
timeFrame: Prior to treatment on Day 3
measure: Mean Response to Subjective Assessment of Patient's Quality of Life (SAoP QoL1) Prior to Treatment on Day 1
timeFrame: Prior to treatment on Day 1
measure: Mean Response to SAoP QoL 2 Prior to Treatment on Day 8
timeFrame: prior to treatment on Day 8
measure: Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1
timeFrame: Prior to treatment on Day 1
measure: Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1
timeFrame: Prior to treatment on Day 1
measure: Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1
timeFrame: Prior to treatment on Day 1
measure: Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1
timeFrame: Prior to treatment on Day 1
measure: Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8
timeFrame: Prior to treatment on Day 8
measure: Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8
timeFrame: Prior to treatment on Day 8
measure: Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8
timeFrame: Prior to treatment on Day 8
measure: Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8
timeFrame: Prior to treatment on Day 8
measure: Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8
timeFrame: Day 1, Day 3, Day 8
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: up to 13 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: