Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms

Study Overview
=================
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.

Official Title
-----------------
A Clinical Study to Evaluate the Efficacy of an Experimental Mouthwash Formulation

Conditions
-----------------
Xerostomia

Intervention / Treatment
-----------------
* Other: Biotene mouthwash
* Other: Mineral Water


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Mouthwash<br>During supervised product use: Participants will rinse with 15 mls of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage is permitted. At Home use:Participants will rinse with 15 mls of mouthwash for 30 seconds and spit out. A maximum of two doses can be used per day. | Other: Biotene mouthwash<br>* During supervised product use: Participants will rinse with 15 mls of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage is permitted. At Home use:Participants will rinse with 15 mls of mouthwash for 30 seconds and spit out. A maximum of two doses can be used per day.<br>|
| Other: Mineral Water<br>During supervised product use:Participants will take a dose (drink) of one measured sip of 15mls of water. At Home use: Participants can sip (drink) water as often as required. Participants will be consuming their own water for home use. | Other: Mineral Water<br>* During supervised product use:Participants will take a dose (drink) of one measured sip of 15mls of water. At Home use: Participants can sip (drink) water as often as required. Participants will be consuming their own water for home use.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Participants answered question 1 'Relieving the discomfort of dry mouth' in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 120 mins post treatment on Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Participants answered to the question 1 'Relieving the discomfort of dry mouth' in PPAQ2 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 30 mins post treatment on Day 8 | 
| Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8 | Participants answered to the question 1 'Relieving the discomfort of dry mouth' in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 60 and 240 mins post treatment on Day 8 | 
| Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8 | Participants answered 3 questions in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 5 mins post treatment on Day 8 | 
| Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 | Participants answered questions, Q2-Q11 in PPAQ2. Q2=Feeling comfortable in the mouth; Q3=Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q=9 Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on a scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 30 mins post treatment on Day 8 | 
| Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 | Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 60 mins. post treatment on Day 8 | 
| Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 | Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 120 mins. post treatment on Day 8 | 
| Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 | Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 240 mins. post treatment on Day 8 | 
| Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8 | Participants answered the 9 questions of PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | prior to treatment on Day 8 | 
| Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1 | Participants answered to the 3 question in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 5 mins post treatment on Day 1 | 
| Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 | Participants answered to the 11 question in PPAQ2. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 30 mins post treatment on Day 1 | 
| Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 | Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 60 mins post treatment on Day 1 | 
| Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 | Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 120 mins post treatment on Day 1 | 
| Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 | Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 240 mins post treatment on Day 1 | 
| Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3 | Participants answered to the 3 questions in PPAQ1 as follows: Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 5 mins post treatment on Day 3 | 
| Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 | Participants answered to the 11 questions in PPAQ2 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 30 mins post treatment on Day 3 | 
| Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 | Participants answered the 14 questions of PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 60 mins. post treatment on Day 3 | 
| Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 | Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 120 mins post treatment on Day 3 | 
| Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 | Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | 240 mins post treatment on Day 3 | 
| Mean Response to PPAQ4 Prior to Treatment on Day 3 | Participants answered to the 9 questions in PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response. | Prior to treatment on Day 3 | 
| Mean Response to Subjective Assessment of Patient's Quality of Life (SAoP QoL1) Prior to Treatment on Day 1 | Participants answered to the 6 questions in SAoP QoL as follows: Q1= Does your dry mouth cause discomfort?; Q2= Does your dry mouth make it uncomfortable to speak?; Q3= Does your dry mouth interrupt your sleep?; Q4= Does your dry mouth affect your social interactions?; Q5= Does your dry mouth cause you to avoid certain foods?; Q6= Does your dry mouth interfere with your daily activities? These questions were rated on a scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response. | Prior to treatment on Day 1 | 
| Mean Response to SAoP QoL 2 Prior to Treatment on Day 8 | Participants answered to the 6 questions in SAoP QoL 2 as follows: Q1= Looking back over the last 7 days, has your dry mouth caused discomfort?; Q2= Looking back over the last 7 days, has your dry mouth made it uncomfortable to speak?; Q3= Looking back over the last 7 days, has your dry mouth interrupted your sleep?; Q4= Looking back over the last 7 days, has your dry mouth affected your social interactions?; Q5= Looking back over the last 7 days, has your dry mouth caused you to avoid certain foods?; Q6= Looking back over the last 7 days, has your dry mouth interfered with your daily activities? These questions were rated on scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response. | prior to treatment on Day 8 | 
| Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 | Number of Participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem? Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, How much do you recognize yourself in following statements, based on the last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people? | Prior to treatment on Day 1 | 
| Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 | Number of Participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people's moods & emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over last week; Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, How much do you agree or disagree that your dry mouth has affected your time with other people over the last week?; Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone; Q27:I feel different because of the things I have to do to look after my mouth. | Prior to treatment on Day 1 | 
| Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 | Number of participants were reported who answered following questions, these questions were about how participants had coped with their dry mouth over the last week with respect to agree or disagree with each of the following questions. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to the toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, and There are other things that help some people with dry mouth. Please tell us how often over the last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth. | Prior to treatment on Day 1 | 
| Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 | Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week & how much they agreed that symptoms were manageable (M). Q40:It's a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life; Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1: Uncomfortable; M2: Bad taste; M3:Loss of Taste; M4: Lips sticking to roof of mouth; M5: Tongue sticking to roof of mouth; M6: Throat dry; M7: No moisture M8:Devoid of any wetness M9:Mouth feels tight ? | Prior to treatment on Day 1 | 
| Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 | Number of participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem?; Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, and How much do you recognize yourself in following statements, based on last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people? | Prior to treatment on Day 8 | 
| Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 | Number of participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people's moods and emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over the last week Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, and How much do you agree or disagree that your dry mouth has affected your time with other people over last week? Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone Q27:I feel different because of the things I have to do to look after my mouth. | Prior to treatment on Day 8 | 
| Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 | Number of participants were reported who answered following questions, these questions are about how you have coped with your dry mouth over last week. Please tell us whether you agree or disagree with each of the statements. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, There are other things that help some people with dry mouth. Please tell us how often over last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth. | Prior to treatment on Day 8 | 
| Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 | Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week & how much they agreed that symptoms were manageable (M). Q40:It's a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life. Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1:Uncomfortable; M2:Bad taste; M3:Loss of Taste; M4:Lips sticking to roof of mouth; M5:Tongue sticking to roof of mouth; M6: Throat dry; M7:No moisture; M8:Devoid of any wetness M9:Mouth feels tight ? | Prior to treatment on Day 8 | 
| Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 | Participants answered 4 questions on PPUSQ as follows: Q1:Which of the following statements best describes how much you liked the product overall?(rated on scale of 1-6, 1=Did not like it at all; 2=Did not like it that much; 3=Like it slightly; 4=Like it somewhat; 5=Like it very much; 6=Like it extremely), Q2:How pleasant would you say the flavor of the product was?(rated on scale of 1-5, 1=Not pleasant at all; 2=Slightly pleasant; 3=Moderately pleasant; 4=Very pleasant; 5=Extremely pleasant), Q3:How gentle would you say the product was?(rated on a scale of 1-7, 1=Not gentle at all; 2=Barely gentle; 3=Slightly gentle; 4=Moderately gentle; 5=Very gentle; 6=Extremely gentle; 7=The most gentle product imaginable), Q4:How fresh would you say your mouth felt after using the product?(rated on a scale of 1-5; 1=Not at all fresh; 2=Not very fresh; 3=Somewhat fresh; 4=Very fresh; 5=Extremely fresh) & response to these questions was reported. Scale score was averaged to calculate the response | Day 1, Day 3, Day 8 | 
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events on administration of investigational product from screening (Day 1) to 5 days after last administration of the product on Day 8. Number of participants with TEAEs were reported. | up to 13 days |