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Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms

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ClinicalTrials.gov Identifier: NCT02641912
Recruitment Status : Completed
First Posted : December 30, 2015
Results First Posted : January 27, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Xerostomia
Interventions Other: Biotene mouthwash
Other: Mineral Water
Enrollment 100

Recruitment Details Participants were recruited at one center in United States of America.
Pre-assignment Details A total of 104 participants were screened. Out of which 100 participants were randomized and stratified based on confirmed Sjögren’s syndrome status (Yes[Y]/No[N]).
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description During supervised product use: Participants rinsed with 15 milliliter (mL) of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day. During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Period Title: Overall Study
Started 53 47
Completed 53 47
Not Completed 0 0
Arm/Group Title Experimental Mouthwash Mineral Water Total
Hide Arm/Group Description During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day. During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use. Total of all reporting groups
Overall Number of Baseline Participants 53 47 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 47 participants 100 participants
50.66  (14.418) 51.57  (14.111) 51.09  (14.210)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 47 participants 100 participants
Female
36
  67.9%
28
  59.6%
64
  64.0%
Male
17
  32.1%
19
  40.4%
36
  36.0%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame 120 mins post treatment on Day 8
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Hide Analysis Population Description
Intent-to-treat (ITT) population which included all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 52 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.50  (1.057) 1.89  (1.149)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Mouthwash, Mineral Water
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0084
Comments [Not Specified]
Method ANOVA
Comments From ANOVA model with factors for treatment and confirmed Sjögren’s syndrome status stratification using Observed Margins option.
Method of Estimation Estimation Parameter Least sqaure (LS) mean difference
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.17 to 1.10
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 30 mins post treatment on Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 39
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.92  (1.053) 2.26  (1.163)
3.Secondary Outcome
Title Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8
Hide Description 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.
Time Frame 60 and 240 mins post treatment on Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 60 min. (n= 52, 38) 2.71  (1.091) 1.97  (1.197)
At 240 min. (n=53, 35) 2.42  (1.151) 1.77  (1.087)
4.Secondary Outcome
Title Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8
Hide Description 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.
Time Frame 5 mins post treatment on Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Having a Immediate Dry Mouth Relief(n=53, 42) 3.57  (1.169) 3.02  (1.297)
Having a Immediate Lubricating Effect(n=53,43) 3.58  (1.247) 2.67  (1.304)
Having a Immediate Moisturizing Effect(n=53,43) 3.55  (1.234) 2.93  (1.183)
5.Secondary Outcome
Title Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8
Hide Description 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.
Time Frame 30 mins post treatment on Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q2: Feeling Comfortable in The Mouth(n=53,39) 3.00  (1.019) 2.28  (1.169)
Q3: Soothing Your Mouth(n=53,38) 3.02  (1.065) 2.34  (1.169)
Q4:Allowing to Speak Without Difficulty(n=46,34) 3.11  (1.059) 2.59  (1.184)
Q5: Effectively Moistens Your Mouth(n= 53,39) 3.02  (1.101) 2.33  (1.177)
Q6: Effectively Lubricates Your Mouth(53,38) 3.04  (1.091) 2.24  (1.173)
Q7: Helping to Freshen Your Breath(n=52,34) 3.06  (1.162) 2.18  (1.336)
Q8: Protecting Your Mouth From Drying Out(53,38) 2.98  (1.118) 2.13  (1.070)
Q9: Providing Whole Mouth Comfort(n=53,39) 3.02  (1.118) 2.18  (1.073)
Q10:Helping to Swallow Without Difficulty(n=49,34) 3.00  (1.041) 2.41  (1.184)
Q11: Helping Mouth Feel 'Normal'(n=53,38) 2.92  (1.053) 2.26  (1.107)
6.Secondary Outcome
Title Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8
Hide Description 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.
Time Frame 60 mins. post treatment on Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q2: Feeling Comfortable in The Mouth(n=53,39) 2.77  (1.086) 2.03  (1.203)
Q3: Soothing Your Mouth(n=52,36) 2.79  (1.109) 1.92  (1.180)
Q4:Allowing to Speak Without Difficulty(n=46,34) 2.96  (1.154) 2.44  (1.284)
Q5: Effectively Moistens Your Mouth(n= 53,37) 2.79  (1.166) 1.95  (1.177)
Q6: Effectively Lubricates Your Mouth(52,38) 2.83  (1.133) 1.95  (1.184)
Q7: Helping to Freshen Your Breath(n=52,32) 2.75  (1.135) 1.94  (1.318)
Q8:Protecting Your Mouth From Drying Out(n=53,38) 2.77  (1.120) 2.00  (1.252)
Q9: Providing Whole Mouth Comfort(n=53,38) 2.75  (1.108) 1.95  (1.207)
Q10:Helping to Swallow Without Difficulty(n=48,32) 2.81  (1.065) 2.22  (1.289)
Q11: Helping Mouth Feel 'Normal'(n=53,38) 2.77  (1.137) 1.97  (1.197)
Q12:Having Long Lasting Dry Mouth Relief(n=53,38) 2.72  (1.116) 1.82  (1.182)
Q13:Long Lasting Lubricating Effect(n=53,36) 2.75  (1.175) 1.72  (1.137)
Q14:Long Lasting Moisturizing Effect(n=53,36) 2.74  (1.163) 1.78  (1.174)
7.Secondary Outcome
Title Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8
Hide Description 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.
Time Frame 120 mins. post treatment on Day 8
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Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q2: Feeling Comfortable in The Mouth(n=53,39) 2.58  (1.117) 1.90  (1.095)
Q3: Soothing Your Mouth(n=53,39) 2.57  (1.152) 1.85  (1.089)
Q4:Allowing to Speak Without Difficulty(n=45,34) 2.67  (1.087) 2.26  (1.189)
Q5: Effectively Moistens Your Mouth(n= 53,39) 2.60  (1.115) 1.77  (1.087)
Q6: Effectively Lubricates Your Mouth(53,38) 2.64  (1.194) 1.74  (1.107)
Q7: Helping to Freshen Your Breath(n=52,33) 2.44  (1.195) 1.82  (1.236)
Q8: Protecting Your Mouth From Drying Out(53,38) 2.49  (1.137) 1.79  (1.143)
Q9: Providing Whole Mouth Comfort(n=52,36) 2.54  (1.111) 1.86  (1.175)
Q10:Helping to Swallow Without Difficulty(n=49,34) 2.63  (1.112) 2.03  (1.167)
Q11: Helping Mouth Feel 'Normal'(n=53,38) 2.64  (1.128) 1.89  (1.085)
Q12:Having Long Lasting Dry Mouth Relief(n=53,37) 2.57  (1.233) 1.68  (0.973)
Q13:Long Lasting Lubricating Effect(n=53,37) 2.57  (1.201) 1.73  (1.071)
Q14:Long Lasting Moisturizing Effect(n=53,36) 2.57  (1.169) 1.75  (1.052)
8.Secondary Outcome
Title Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8
Hide Description 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.
Time Frame 240 mins. post treatment on Day 8
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Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q2: Feeling Comfortable in The Mouth(n=53,37) 2.47  (1.154) 1.81  (1.101)
Q3: Soothing Your Mouth(n=53,37) 2.40  (1.182) 1.68  (1.002)
Q4:Allowing to Speak Without Difficulty(n=46,32) 2.70  (1.113) 2.13  (1.212)
Q5: Effectively Moistens Your Mouth(n= 53,37) 2.45  (1.202) 1.73  (1.071)
Q6: Effectively Lubricates Your Mouth(53,36) 2.45  (1.218) 1.78  (1.098)
Q7: Helping to Freshen Your Breath(n=51,31) 2.45  (1.189) 1.74  (1.182)
Q8: Protecting Your Mouth From Drying Out(53,37) 2.43  (1.201) 1.68  (1.056)
Q9: Providing Whole Mouth Comfort(n=53,37) 2.43  (1.135) 1.73  (1.018)
Q10:Helping to Swallow Without Difficulty(n=48,32) 2.63  (1.214) 1.88  (1.129)
Q11: Helping Mouth Feel 'Normal'(n=53,36) 2.38  (1.147) 1.78  (1.098)
Q12:Having Long Lasting Dry Mouth Relief(n=53,37) 2.36  (1.145) 1.76  (1.140)
Q13:Long Lasting Lubricating Effect(n=53,37) 2.34  (1.192) 1.65  (1.086)
Q14:Long Lasting Moisturizing Effect(n=53,37) 2.40  (1.182) 1.65  (1.086)
9.Secondary Outcome
Title Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8
Hide Description 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.
Time Frame prior to treatment on Day 8
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Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Providing Relief All Night(n=47,31) 2.68  (1.163) 1.71  (1.160)
Reducing Number of Wake Up from Dry Mouth(n=41,27) 2.80  (1.209) 1.81  (1.272)
Feeling Less Parched When You Wake Up(n=47,32) 2.51  (1.196) 1.84  (1.110)
Having a Long Lasting Dry Mouth Relief(n=47,32) 2.68  (1.270) 1.75  (0.950)
Having a Long Lasting Lubricating Effect(n=49,33) 2.63  (1.253) 1.70  (0.918)
Having a Long Lasting Moisturizing Effect(n=48,31) 2.69  (1.257) 1.65  (0.915)
Having an Overall Dry Mouth Relief(n=49,34) 2.73  (1.132) 1.76  (1.017)
Having an Overall Lubrication Effect(n=49,32) 2.63  (1.202) 1.78  (0.975)
Having an Overall Moisturizing Effect(n=49,33) 2.67  (1.197) 1.70  (0.984)
10.Secondary Outcome
Title Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1
Hide Description 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.
Time Frame 5 mins post treatment on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Having a Immediate Dry Mouth Relief(n=51,45) 3.55  (0.986) 3.11  (1.402)
Having a Immediate Lubricating Effect(n=53,43) 3.43  (0.971) 3.02  (1.371)
Having a Immediate Moisturizing Effect(n=53,45) 3.57  (1.029) 3.38  (1.211)
11.Secondary Outcome
Title Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1
Hide Description 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.
Time Frame 30 mins post treatment on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q1:Relieving the Discomfort Of Dry Mouth(n=53,45) 2.92  (0.958) 2.33  (1.261)
Q2:Feeling Comfortable in The Mouth(n=52,45) 2.92  (0.926) 2.36  (1.151)
Q3:Soothing Your Mouth(n=52,45) 2.94  (0.895) 2.29  (1.180)
Q4:Allowing to Speak Without Difficulty(n=46,41) 3.13  (0.833) 2.51  (1.075)
Q5: Effectively Moistens Your Mouth(n= 53,44) 3.08  (0.997) 2.41  (1.226)
Q6: Effectively Lubricates Your Mouth(n=53,45) 3.06  (0.949) 2.29  (1.160)
Q7: Helping to Freshen Your Breath(n=52,38) 3.21  (0.997) 2.03  (1.219)
Q8: Protecting Your Mouth From Drying Out(n=53,43) 2.92  (0.997) 2.07  (1.280)
Q9: Providing Whole Mouth Comfort(n=53,43) 3.06  (0.949) 2.35  (1.289)
Q10:Helping to Swallow Without Difficulty(n=51,43) 3.06  (0.904) 2.60  (1.348)
Q11: Helping Mouth Feel 'Normal'(n=53,44) 3.02  (0.951) 2.32  (1.377)
12.Secondary Outcome
Title Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1
Hide Description 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.
Time Frame 60 mins post treatment on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q1:Relieving the Discomfort Of Dry Mouth(n=53,40) 2.60  (1.044) 2.15  (1.272)
Q2:Feeling Comfortable in The Mouth(n=53,44) 2.68  (0.915) 2.18  (1.167)
Q3:Soothing Your Mouth(n=52,42) 2.65  (0.926) 2.19  (1.234)
Q4:Allowing to Speak Without Difficulty(n=47,39) 3.04  (0.955) 2.59  (1.208)
Q5: Effectively Moistens Your Mouth(n= 53,43) 2.79  (1.150) 2.21  (1.407)
Q6: Effectively Lubricates Your Mouth(53,41) 2.70  (1.153) 2.02  (1.214)
Q7: Helping to Freshen Your Breath(n=51,38) 2.86  (1.059) 1.82  (1.159)
Q8:Protecting Your Mouth From Drying Out(n=53,41) 2.49  (1.120) 2.02  (1.275)
Q9: Providing Whole Mouth Comfort(n=53,41) 2.58  (1.027) 2.17  (1.160)
Q10:Helping to Swallow Without Difficulty(n=51,40) 2.65  (1.036) 2.30  (1.244)
Q11: Helping Mouth Feel 'Normal'(n=53,43) 2.62  (1.042) 2.05  (1.194)
Q12:Having Long Lasting Dry Mouth Relief(n=53,43) 2.55  (1.136) 1.88  (1.219)
Q13:Long Lasting Lubricating Effect(n=53,41) 2.57  (1.152) 1.95  (1.264)
Q14:Long Lasting Moisturizing Effect(n=53,41) 2.62  (1.113) 2.00  (1.245)
13.Secondary Outcome
Title Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1
Hide Description 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.
Time Frame 120 mins post treatment on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q1:Relieving the Discomfort Of Dry Mouth(n=52,40) 2.48  (1.146) 2.13  (1.324)
Q2:Feeling Comfortable in The Mouth(n=52,40) 2.56  (1.145) 2.10  (1.236)
Q3:Soothing Your Mouth(n=52,40) 2.48  (1.075) 2.13  (1.305)
Q4:Allowing to Speak Without Difficulty(n=48,40) 2.75  (1.194) 2.50  (1.240)
Q5: Effectively Moistens Your Mouth(n= 52,39) 2.52  (1.229) 2.23  (1.441)
Q6: Effectively Lubricates Your Mouth(52,39) 2.50  (1.146) 2.10  (1.294)
Q7: Helping to Freshen Your Breath(n=51,31) 2.59  (1.203) 2.00  (1.265)
Q8:Protecting Your Mouth From Drying Out(n=53,40) 2.30  (1.153) 2.00  (1.281)
Q9: Providing Whole Mouth Comfort(n=53,39) 2.45  (1.202) 2.21  (1.260)
Q10:Helping to Swallow Without Difficulty(n=52,39) 2.48  (1.146) 2.28  (1.317)
Q11: Helping Mouth Feel 'Normal'(n=52,40) 2.50  (1.146) 2.28  (1.261)
Q12:Having Long Lasting Dry Mouth Relief(n=52,39) 2.42  (1.194) 1.97  (1.347)
Q13:Long Lasting Lubricating Effect(n=53,37) 2.36  (1.226) 1.92  (1.211)
Q14:Long Lasting Moisturizing Effect(n=53,39) 2.42  (1.167) 1.95  (1.255)
14.Secondary Outcome
Title Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1
Hide Description 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.
Time Frame 240 mins post treatment on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q1:Relieving the Discomfort Of Dry Mouth(n=53,37) 2.38  (1.060) 2.03  (1.213)
Q2:Feeling Comfortable in The Mouth(n=53,39) 2.49  (1.137) 2.08  (1.156)
Q3:Soothing Your Mouth(n=52,40) 2.52  (1.146) 2.08  (1.163)
Q4:Allowing to Speak Without Difficulty(n=47,35) 2.60  (1.116) 2.51  (1.222)
Q5: Effectively Moistens Your Mouth(n= 52,40) 2.48  (1.196) 2.00  (1.132)
Q6: Effectively Lubricates Your Mouth(52,39) 2.48  (1.163) 1.97  (1.088)
Q7: Helping to Freshen Your Breath(n=50,33) 2.28  (1.179) 1.64  (1.025)
Q8:Protecting Your Mouth From Drying Out(n=53,38) 2.23  (1.137) 1.84  (1.175)
Q9: Providing Whole Mouth Comfort(n=53,38) 2.38  (1.147) 2.08  (1.148)
Q10:Helping to Swallow Without Difficulty(n=51,36) 2.37  (1.113) 2.25  (1.339)
Q11: Helping Mouth Feel 'Normal'(n=53,39) 2.26  (1.163) 2.08  (1.133)
Q12:Having Long Lasting Dry Mouth Relief(n=51,38) 2.27  (1.168) 1.89  (1.110)
Q13: Having a Long Lasting Lubricating Effect 2.33  (1.227) 1.85  (1.040)
Q14: Having a Long Lasting moisturizing effect 2.33  (1.160) 1.92  (1.133)
15.Secondary Outcome
Title Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3
Hide Description 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.
Time Frame 5 mins post treatment on Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 45
Mean (Standard Deviation)
Unit of Measure: score on a scale
Having a Immediate Dry Mouth Relief(n=53,45) 3.55  (1.119) 3.16  (1.397)
Having a Immediate Lubricating Effect(n=53,44) 3.47  (1.103) 2.80  (1.440)
Having a Immediate Moisturizing Effect(n=53,44) 3.51  (1.067) 2.89  (1.450)
16.Secondary Outcome
Title Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3
Hide Description 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.
Time Frame 30 mins post treatment on Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q1:Relieving the Discomfort Of Dry Mouth(n=53,41) 2.91  (1.043) 2.29  (1.167)
Q2:Feeling Comfortable in The Mouth(n=53,40) 2.96  (1.055) 2.35  (1.122)
Q3:Soothing Your Mouth(n=53,40) 2.91  (1.097) 2.35  (1.272)
Q4:Allowing to Speak Without Difficulty(n=46,36) 3.11  (1.100) 2.94  (1.286)
Q5: Effectively Moistens Your Mouth(n= 53,42) 2.92  (1.035) 2.26  (1.270)
Q6: Effectively Lubricates Your Mouth(53,40) 2.85  (1.045) 2.18  (1.259)
Q7: Helping to Freshen Your Breath(n=53,33) 2.94  (1.134) 2.06  (1.197)
Q8:Protecting Your Mouth From Drying Out(n=53,41) 2.83  (1.122) 2.02  (1.235)
Q9: Providing Whole Mouth Comfort(n=53,42) 2.87  (1.057) 2.24  (1.246)
Q10:Helping to Swallow Without Difficulty(n=49,41) 3.00  (1.000) 2.34  (1.257)
Q11: Helping Mouth Feel 'Normal'(n=53,42) 2.92  (1.053) 2.24  (1.246)
17.Secondary Outcome
Title Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3
Hide Description 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.
Time Frame 60 mins. post treatment on Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q1:Relieving the Discomfort of Dry Mouth(n=53,39) 2.64  (1.058) 2.10  (1.273)
Q2:Feeling Comfortable in the Mouth(n=53,39) 2.72  (1.133) 2.21  (1.260)
Q3:Soothing Your Mouth(n=53,39) 2.66  (1.055) 2.21  (1.281)
Q4:Allowing to Speak Without Difficulty(n=46,35) 2.89  (1.197) 2.63  (1.285)
Q5: Effectively Moistens Your Mouth(n= 53,40) 2.60  (1.132) 2.23  (1.230)
Q6: Effectively Lubricates Your Mouth(53,39) 2.60  (1.115) 2.13  (1.361)
Q7: Helping to Freshen Your Breath(n=52,34) 2.75  (1.169) 1.91  (1.190)
Q8:Protecting Your Mouth From Drying Out(n=53,39) 2.60  (1.132) 1.92  (1.201)
Q9: Providing Whole Mouth Comfort(n=53,40) 2.75  (1.072) 2.08  (1.269)
Q10:Helping to Swallow Without Difficulty(n=49,37) 2.65  (1.071) 2.41  (1.235)
Q11: Helping Mouth Feel 'Normal'(n=53,41) 2.58  (1.046) 2.20  (1.229)
Q12:Having Long Lasting Dry Mouth Relief(n=53,39) 2.55  (1.048) 1.92  (1.326)
Q13:Long Lasting Lubricating Effect(n=53,40) 2.55  (1.048) 2.00  (1.301)
Q14:Long Lasting Moisturizing Effect(n=53,40) 2.62  (1.096) 1.98  (1.291)
18.Secondary Outcome
Title Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3
Hide Description 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.
Time Frame 120 mins post treatment on Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q1:Relieving the Discomfort of Dry Mouth(n=53,39) 2.60  (1.261) 1.95  (1.297)
Q2:Feeling Comfortable in the Mouth(n=53,41) 2.57  (1.169) 1.90  (1.114)
Q3:Soothing Your Mouth(n=53,40) 2.51  (1.234) 1.93  (1.163)
Q4:Allowing to Speak Without Difficulty(n=47,35) 2.77  (1.127) 2.51  (1.245)
Q5: Effectively Moistens Your Mouth(n= 53,41) 2.49  (1.203) 1.93  (1.212)
Q6: Effectively Lubricates Your Mouth(53,40) 2.53  (1.219) 1.95  (1.280)
Q7: Helping to Freshen Your Breath(n=52,34) 2.42  (1.242) 1.79  (1.149)
Q8:Protecting Your Mouth From Drying Out(n=53,38) 2.45  (1.153) 1.95  (1.184)
Q9: Providing Whole Mouth Comfort(n=53,40) 2.66  (1.208) 1.90  (1.150)
Q10:Helping to Swallow Without Difficulty(n=50,38) 2.50  (1.233) 2.16  (1.263)
Q11: Helping Mouth Feel 'Normal'(n=53,39) 2.55  (1.202) 2.05  (1.213)
Q12:Having Long Lasting Dry Mouth Relief(n=53,37) 2.49  (1.234) 1.89  (1.308)
Q13:Long Lasting Lubricating Effect(n=53,39) 2.43  (1.185) 1.87  (1.260)
Q14:Long Lasting Moisturizing Effect(n=53,41) 2.45  (1.218) 1.90  (1.281)
19.Secondary Outcome
Title Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3
Hide Description 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.
Time Frame 240 mins post treatment on Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Q1:Relieving the Discomfort of Dry Mouth(n=52,39) 2.37  (1.121) 1.77  (1.180)
Q2:Feeling Comfortable in the Mouth(n=52,40) 2.42  (1.194) 1.80  (1.043)
Q3:Soothing Your Mouth(n=52,39) 2.31  (1.130) 1.77  (1.111)
Q4:Allowing to Speak Without Difficulty(n=45,34) 2.49  (1.121) 2.26  (1.286)
Q5: Effectively Moistens Your Mouth(n= 52,38) 2.29  (1.143) 1.76  (1.149)
Q6: Effectively Lubricates Your Mouth(52,39) 2.29  (1.160) 1.74  (1.141)
Q7: Helping to Freshen Your Breath(n=51,33) 2.33  (1.178) 1.76  (1.173)
Q8:Protecting Your Mouth From Drying Out(n=52,39) 2.25  (1.153) 1.74  (1.117)
Q9: Providing Whole Mouth Comfort(n=52,40) 2.31  (1.164) 1.75  (1.056)
Q10:Helping to Swallow Without Difficulty(n=48,38) 2.38  (1.123) 1.92  (1.217)
Q11: Helping Mouth Feel 'Normal'(n=52,38) 2.33  (1.184) 1.84  (1.103)
Q12:Having Long Lasting Dry Mouth Relief(n=52,38) 2.31  (1.164) 1.71  (1.206)
Q13:Long Lasting Lubricating Effect(n=52,39) 2.23  (1.165) 1.72  (1.169)
Q14:Long Lasting Moisturizing Effect(n=52,39) 2.23  (1.148) 1.77  (1.158)
20.Secondary Outcome
Title Mean Response to PPAQ4 Prior to Treatment on Day 3
Hide Description 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.
Time Frame Prior to treatment on Day 3
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Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Providing Relief All Night(n=51,34) 2.57  (1.100) 2.18  (1.336)
Reducing Number of Wake Up from Dry Mouth(n=47,33) 2.81  (1.173) 2.18  (1.334)
Feeling Less Parched When You Wake Up(n=50,36) 2.52  (1.129) 2.11  (1.214)
Having a Long Lasting Dry Mouth Relief(n=53,36) 2.43  (1.047) 1.86  (1.125)
Having a Long Lasting Lubricating Effect(n=53,36) 2.51  (1.067) 2.00  (1.219)
Having a Long Lasting Moisturizing Effect(n=53,36) 2.47  (1.012) 1.86  (1.150)
Having an Overall Dry Mouth Relief(n=53,37) 2.45  (1.048) 1.95  (1.177)
Having an Overall Lubrication Effect(n=53,36) 2.47  (1.049) 2.03  (1.183)
Having an Overall Moisturizing Effect(n=53,37) 2.45  (1.084) 2.03  (1.166)
21.Secondary Outcome
Title Mean Response to Subjective Assessment of Patient’s Quality of Life (SAoP QoL1) Prior to Treatment on Day 1
Hide Description 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.
Time Frame Prior to treatment on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Does Your Dry Mouth Cause Discomfort? 2.51  (1.310) 2.74  (1.073)
Does Your Dry Mouth Make Uncomfortable To Speak? 2.13  (1.256) 2.06  (1.111)
Does Your Dry Mouth Interrupt Your Sleep? 2.08  (1.253) 2.13  (1.454)
Does Your Dry Mouth Affect Your Social Interaction 1.58  (1.247) 1.51  (1.349)
Does Your Dry Mouth Cause To Avoid Certain Foods? 1.87  (1.532) 1.94  (1.451)
Does Dry Mouth Interfere Your Daily Activities? 1.42  (1.322) 1.36  (1.326)
22.Secondary Outcome
Title Mean Response to SAoP QoL 2 Prior to Treatment on Day 8
Hide Description 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.
Time Frame prior to treatment on Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Has Your Dry Mouth Cause Discomfort? 1.58  (1.216) 2.15  (1.215)
Has Your Dry Mouth Make Uncomfortable To Speak? 1.00  (1.127) 1.32  (1.144)
Has Your Dry Mouth Interrupt Your Sleep? 1.15  (1.215) 1.66  (1.493)
Has Your Dry Mouth Affect Social Interactions? 0.70  (1.030) 1.02  (1.242)
Has Your Dry Mouth Cause To Avoid Certain Foods? 1.11  (1.368) 1.49  (1.333)
Has Your Mouth Interfere Daily Activities? 0.83  (1.033) 0.87  (1.227)
23.Secondary Outcome
Title Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1
Hide Description 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?
Time Frame Prior to treatment on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Number of participants
Q1:Never in the last week 3 2
Q1: A few days 10 5
Q1:Most days 9 6
Q1: Every day 13 11
Q1: Several times every day 8 11
Q1: All of the time 10 12
Q2: Strongly disagree 8 8
Q2: Disagree 12 12
Q2: Disagree a little 5 6
Q2: Agree a little 13 6
Q2: Agree 14 10
Q2: Strongly Agree 1 5
Q3: Strongly disagree 3 2
Q3: Disagree 2 0
Q3: Disagree a little 2 2
Q3: Agree a little 7 9
Q3: Agree 26 23
Q3: Strongly agree 13 11
Q4: Strongly disagree 2 3
Q4: Disagree 5 6
Q4: Disagree a little 5 4
Q4: Agree a little 15 10
Q4: Agree 16 15
Q4: Strongly agree 10 9
Q5: Strongly disagree 7 8
Q5: Disagree 10 10
Q5: Disagree a little 4 4
Q5: Agree a little 14 11
Q5:Agree 11 10
Q5: Strongly Agree 7 4
Q6: Strongly disagree 5 4
Q6: Disagree 3 3
Q6:Disagree a little 4 7
Q6: Agree a little 18 9
Q6: Agree 16 15
Q6: Strongly agree 7 9
Q7: Strongly disagree 5 5
Q7: Disagree 5 3
Q7: Disagree a little 6 4
Q7: Agree a little 17 10
Q7: Agree 14 15
Q7: Strongly agree 6 10
Q8: Strongly disagree 0 1
Q8: Disagree 2 1
Q8: Disagree a little 2 0
Q8: Agree a little 12 9
Q8: Agree 21 20
Q8: Strongly agree 16 16
Q9: Strongly disagree 1 0
Q9: Disagree 1 2
Q9: Disagree a little 2 0
Q9: Agree a little 9 10
Q9: Agree 22 20
Q9: Strongly agree 18 15
Q10: Strongly disagree 3 2
Q10: Disagree 9 6
Q10: Disagree a little 5 3
Q10: Agree a little 10 12
Q10: Agree 15 16
Q10: Strongly agree 11 8
Q11: Strongly disagree 2 3
Q11: Disagree 5 6
Q11: Disagree a little 1 4
Q11: Agree a little 18 10
Q11: Agree 13 9
Q11: Strongly agree 14 15
Q12: Strongly diaagree 3 3
Q12: Disagree 7 6
Q12: Disagree a little 3 3
Q12: Agree a little 17 11
Q12: Agree 13 16
Q12: Strongly agree 10 8
Q13: Strongly disagree 2 3
Q13: Disagree 3 4
Q13: Disagree a little 7 2
Q13: Agree a little 14 10
Q13: Agree 11 13
Q13: Strongly agree 16 15
Q14: Strongly disagree 3 5
Q14: Disagree 7 6
Q14: Disagree a little 4 4
Q14: Agree a little 14 13
Q14: Agree 18 15
Q14: Strongly agree 7 4
Q15: Strongly disagree 2 0
Q15: Disagree 5 4
Q15: Disagree a little 1 6
Q15: Agree a little 9 6
Q15: Agree 8 13
Q15: Strongly agree 28 18
24.Secondary Outcome
Title Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1
Hide Description 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.
Time Frame Prior to treatment on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Number of participants
Q16: Never 11 7
Q16: A few days 14 19
Q16: Most days 9 6
Q16: Every day 6 4
Q16: A few times every day 2 5
Q16: Many times every day 11 6
Q17: Never 16 13
Q17: A few days 7 14
Q17: Most days 9 8
Q17: Every day 6 3
Q17: A few times every day 10 6
Q17: Many times every day 5 3
Q18: Never 22 19
Q18: A few days 12 7
Q18: Most days 5 9
Q18: Every day 4 3
Q18: A few times every day 4 5
Q18: Many times every day 6 4
Q19: Never 21 13
Q19: A few days 8 12
Q19: Most days 6 6
Q19: Every day 6 6
Q19: A few times every day 2 6
Q19: Many times every day 10 4
Q20: Strongly disagree 10 6
Q20: Disagree 8 9
Q20: Disagree a little 4 6
Q20: Agree a little 18 16
Q20: Agree 8 7
Q20: Strongly agree 5 3
Q21: Strongly disagree 8 8
Q21: Disagree 9 14
Q21: Disagree a little 4 6
Q21: Agree a little 16 6
Q21: Agree 11 7
Q21: Strongly agree 5 6
Q22: Strongly disagree 8 5
Q22: Disagree 8 10
Q22: Disagree a little 6 1
Q22: Agree a little 8 11
Q22: Agree 16 15
Q22: Strongly agree 7 5
Q23: Strongly disagree 7 5
Q23: Disagree 7 9
Q23: Disagree a little 8 4
Q23: Agree a little 10 11
Q23: Agree 12 12
Q23: Strongly agree 9 6
Q24: Strongly disagree 7 8
Q24: Disagree 13 9
Q24: Disagree a little 9 7
Q24: Agree a little 13 9
Q24: Agree 6 7
Q24: Strongly agree 5 7
Q25: Strongly disagree 5 6
Q25: Disagree 10 5
Q25: Disagree a little 6 6
Q25: Agree a little 12 12
Q25: Agree 8 12
Q25: Strongly agree 12 6
Q26: Strongly disagree 9 7
Q26: Disagree 9 16
Q26:Disagree a little 9 7
Q26: Agree a little 20 11
Q26: Agree 3 4
Q26: Strongly agree 3 2
Q27: Strongly disagree 6 9
Q27: Disagree 11 7
Q27: Disagree a little 7 7
Q27: Agree a little 13 12
Q27: Agree 11 8
Q27: Strongly agree 5 4
25.Secondary Outcome
Title Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1
Hide Description 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.
Time Frame Prior to treatment on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Number of participants
Q28: Strongly disagree 2 0
Q28: Disagree 1 1
Q28: Disagree a little 0 1
Q28: Agree a little 4 5
Q28: Agree 14 13
Q28: Strongly agree 32 27
Q29: Strongly disagree 4 1
Q29: Disagree 5 0
Q29: Disagree a little 0 5
Q29: Agree a little 6 8
Q29: Agree 16 14
Q29: Strongly agree 22 19
Q30: Strongly disagree 4 2
Q30: Disagree 3 5
Q30: Disagree a little 3 3
Q30: Agree a little 12 13
Q30: Agree 10 11
Q30: Strongly agree 21 13
Q31: Strongly disagree 3 2
Q31: Disagree 0 2
Q31: Disagree a little 2 0
Q31: Agree a little 5 5
Q31: Agree 14 9
Q31: Strongly agree 29 29
Q32: Strongly disagree 4 2
Q32: Disagree 6 5
Q32: Disagree a little 2 3
Q32: Agree a little 15 12
Q32: Agree 14 14
Q32: Strongly agree 12 11
Q33: Strongly disagree 2 1
Q33: Disagree 6 3
Q33: Disagree a little 6 4
Q33: Agree a little 12 7
Q33: Agree 15 20
Q33: Strongly agree 12 12
Q34: Strongly disagree 6 2
Q34: Disagree 12 11
Q34: Disagree a little 5 6
Q34: Agree a little 11 9
Q34: Agree 10 11
Q34: Strongly agree 9 8
Q35: Strongly disagree 6 2
Q35: Disagree 11 7
Q35: Disagree a little 4 5
Q35: Agree a little 6 8
Q35: Agree 14 12
Q35: Strongly agree 12 13
Q36: Never in the last week 20 17
Q36: One or two days 5 7
Q36: Most days 10 7
Q36: Every day 3 1
Q36: A few times every day 6 5
Q36: Many times every day 9 10
Q37: Never in the last week 7 8
Q37: One or two days 8 9
Q37: Most days 9 7
Q37: Every day 10 10
Q37: A few times every day 6 5
Q37: Many times every day 13 8
Q38: Never in the last week 13 12
Q38: One or two days 8 11
Q38: Most days 8 5
Q38: Every day 8 4
Q38: A few times every day 10 4
Q38: Many times every day 6 11
Q39: Never in the last week 10 11
Q39: One or two days 6 3
Q39: Most days 10 7
Q39: Every day 8 9
Q39: A few times every day 6 3
Q39: Many times every day 13 14
26.Secondary Outcome
Title Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1
Hide Description 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 ?
Time Frame Prior to treatment on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Number of participants
Q40: Strongly Disagree 3 3
Q40: Disagree 6 6
Q40: Disagree a little 2 4
Q40: Agree a little 13 11
Q40: Agree 17 16
Q40: Strongly agree 12 7
Q41: Strongly disagree 5 7
Q41: Disagree 12 11
Q41: Disagree a little 6 7
Q41: Agree a little 15 4
Q41: Agree 6 12
Q41: Strongly agree 9 6
Q42: Strongly disagree 6 4
Q42: Disagree 12 7
Q42: Disagree a little 3 6
Q42: Agree a little 15 11
Q42: Agree 6 11
Q42: Strongly agree 11 8
Q43: Strongly disagree 2 2
Q43: Disagree 2 1
Q43: Disagree a little 3 0
Q43: Agree a little 10 10
Q43: Agree 16 21
Q43: Strongly agree 20 13
Q44: Strongly disagree 2 2
Q44: Disagree 8 2
Q44: Disagree a little 4 6
Q44: Agree a little 12 14
Q44: Agree 13 14
Q44: Strongly agree 14 9
Q45: Strongly disagree 6 4
Q45: Disagree 12 10
Q45: Disagree a little 7 8
Q45: Agree a little 14 9
Q45: Agree 6 10
Q45: Strongly agree 8 6
Q46: Excellent 5 3
Q46: Very Good 12 10
Q46: Good 20 14
Q46: Fair 13 15
Q46: Poor 3 5
QM1: Strongly disagree 2 2
QM1: Disagree 9 1
QM1: Disagree a little 5 4
QM1: Agree a little 17 12
QM1: Agree 15 17
QM1: Strongly agree 5 11
QM2: Strongly disagree 4 4
QM2: Disagree 11 4
QM2: Disagree a little 8 3
QM2: Agree a little 13 13
QM2: Agree 11 15
QM2: Strongly agree 6 8
QM3: Strongly disagree 5 6
QM3: Disagree 17 5
QM3: Disagree a little 8 12
QM3: Agree a little 12 12
QM3: Agree 9 11
QM3: Strongly agree 2 1
QM4: Strongly disagree 5 3
QM4: Disagree 10 3
QM4: Disagree a little 6 5
QM4: Agree a little 17 11
QM4: Agree 11 17
QM4: Strongly agree 4 8
QM5: Strongly disagree 6 3
QM5: Disagree 9 3
QM5: Disagree a little 6 4
QM5: Agree a little 16 11
QM5: Agree 13 16
QM5: Strongly agree 3 10
QM6: Strongly disagree 1 1
QM6: Disagree 7 1
QM6: Disagree a little 2 3
QM6: Agree a little 18 9
QM6: Agree 17 17
QM6: Strongly agree 8 16
QM7: Strongly disagree 3 0
QM7: Disagree 7 3
QM7: Disagree a little 2 4
QM7: Agree a little 15 7
QM7: Agree 16 17
QM7: Strongly agree 10 16
QM8: Strongly disagree 3 2
QM8: Disagree 7 4
QM8: Disagree a little 5 4
QM8: Agree a little 16 7
QM8: Agree 15 22
QM8: Strongly agree 7 8
QM9: Strongly disagree 6 4
QM9: Disagree 13 3
QM9: Disagree a little 6 4
QM9: Agree a little 12 11
QM9: Agree 10 18
QM9: Strongly agree 6 7
27.Secondary Outcome
Title Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8
Hide Description 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?
Time Frame Prior to treatment on Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Number of participants
Q1: Never in the last week 8 2
Q1: A few days 20 8
Q1: Most days 7 14
Q1: Every day 7 10
Q1: Several times every day 3 8
Q1: All of the time 8 5
Q2: Strongly disagree 14 12
Q2: Disagree 11 11
Q2: Disagree a little 4 6
Q2: Agree a little 13 7
Q2: Agree 9 9
Q2: Strongly agree 2 2
Q3: Strongly disagree 6 5
Q3: Disagree 6 2
Q3: Disagree a little 8 2
Q3: Agree a little 12 9
Q3: Agree 13 21
Q3: Strongly agree 8 8
Q4: Strongly disagree 6 7
Q4: Disagree 6 7
Q4: Disagree a little 7 3
Q4: Agree a little 19 11
Q4: Agree 12 12
Q4: Strongly agree 3 7
Q5: Strongly disagree 13 11
Q5: Disagree 13 12
Q5: Disagree a little 6 7
Q5: Agree a little 14 6
Q5: Agree 5 8
Q5: Strongly agree 2 3
Q6: Strongly disagree 9 5
Q6: Disagree 7 3
Q6: Disagree a little 7 8
Q6: Agree a little 14 9
Q6: Agree 12 15
Q6: Strongly agree 4 7
Q7: Strongly disagree 11 3
Q7: Disagree 9 5
Q7: Disagree a little 9 10
Q7: Agree a little 14 8
Q7: Agree 9 16
Q7: Strongly agree 1 5
Q8: Strongly disagree 3 4
Q8: Disagree 3 1
Q8: Disagree a little 4 2
Q8: Agree a little 17 9
Q8: Agree 16 18
Q8: Strongly agree 10 13
Q9: Strongly disagree 4 3
Q9: Disagree 4 4
Q9: Disagree a little 5 0
Q9: Agree a little 14 9
Q9: Agree 14 21
Q9: Strongly agree 12 10
Q10: Strongly disagree 8 4
Q10: Disagree 8 5
Q10: Disagree a little 7 3
Q10: Agree a little 12 14
Q10: Agree 12 15
Q10: Strongly agree 6 6
Q11: Strongly disagree 6 4
Q11: Disagree 10 8
Q11: Disagree a little 7 3
Q11: Agree a little 13 10
Q11: Agree 11 16
Q11: Strongly agree 6 6
Q12: Strongly disagree 7 2
Q12: Disagree 11 11
Q12: Disagree a little 10 5
Q12: Agree a little 14 11
Q12: Agree 8 13
Q12: Strongly agree 3 5
Q13: Strongly disagree 6 4
Q13: Disagree 11 9
Q13: Disagree a little 11 1
Q13: Agree a little 15 10
Q13: Agree 5 14
Q13: Strongly agree 5 9
Q14: Strongly disagree 6 5
Q14: Disagree 14 13
Q14: Disagree a little 11 6
Q14: Agree a little 12 12
Q14: Agree 9 8
Q14: Strongly agree 1 3
Q15: Strongly disagree 5 5
Q15: Disagree 7 5
Q15: Disagree a little 6 0
Q15: Agree a little 13 7
Q15: Agree 12 16
Q15: Strongly agree 10 14
28.Secondary Outcome
Title Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8
Hide Description 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.
Time Frame Prior to treatment on Day 8
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Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Number of participants
Q16: Never 16 15
Q16: A few days 21 9
Q16: Most days 8 6
Q16: Every day 3 7
Q16: A few times every day 2 6
Q16: Many times every day 3 4
Q17: Never 20 12
Q17: A few days 20 20
Q17: Most days 8 3
Q17: Every day 0 3
Q17: A few times every day 3 8
Q17: Many times every day 2 1
Q18: Never 33 19
Q18: A few days 12 15
Q18: Most days 2 5
Q18: Every day 3 2
Q18: A few times every day 1 3
Q18: Many times every day 2 3
Q19: Never 23 15
Q19: A few days 13 8
Q19: Most days 7 11
Q19: Every day 7 8
Q19: A few times every day 2 2
Q19: Many times every day 1 3
Q20: Strongly disagree 14 13
Q20: Disagree 17 13
Q20: Disagree a little 3 5
Q20: Agree a little 12 7
Q20: Agree 7 7
Q20: Strongly agree 0 2
Q21: Strongly disagree 13 11
Q21: Disagree 18 10
Q21: Disagree a little 1 8
Q21: Agree a little 14 7
Q21: Agree 6 8
Q21: Strongly agree 1 3
Q22: Strongly disagree 11 10
Q22: Disagree 14 10
Q22: Disagree a little 3 5
Q22: Agree a little 17 7
Q22: Agree 7 12
Q22: Strongly agree 1 3
Q23: Strongly disagree 11 9
Q23: Disagree 14 8
Q23: Disagree a little 4 4
Q23: Agree a little 13 10
Q23: Agree 7 11
Q23: Strongly agree 4 5
Q24: Strongly disagree 13 12
Q24: Disagree 15 9
Q24: Disagree a little 4 8
Q24: Agree a little 14 8
Q24: Agree 4 8
Q24: Strongly agree 3 2
Q25: Strongly disagree 10 7
Q25: Disagree 9 8
Q25: Disagree a little 9 3
Q25: Agree a little 12 11
Q25: Agree 9 13
Q25: Strongly agree 4 5
Q26: Strongly disagree 15 12
Q26: Disagree 15 10
Q26: Disagree a little 5 10
Q26: Agree a little 16 11
Q26: Agree 2 2
Q26: Strongly agree 0 2
Q27: Strongly disagree 12 12
Q27: Disagree 14 9
Q27: Disagree a little 2 2
Q27: Agree a little 17 10
Q27: Agree 7 8
Q27: Strongly agree 1 6
29.Secondary Outcome
Title Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8
Hide Description 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.
Time Frame Prior to treatment on Day 8
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Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Number of participants
Q28: Strongly disagree 2 2
Q28: Disagree 0 1
Q28: Disagree a little 5 3
Q28: Agree a little 15 3
Q28: Agree 11 14
Q28: Strongly agree 20 24
Q29: Strongly disagree 4 1
Q29: Disagree 9 2
Q29: Disagree a little 6 3
Q29: Agree a little 12 10
Q29: Agree 12 12
Q29: Strongly agree 10 19
Q30: Strongly disagree 7 3
Q30: Disagree 5 7
Q30: Disagree a little 4 4
Q30: Agree a little 20 10
Q30: Agree 10 13
Q30: Strongly agree 7 10
Q31: Strongly disagree 6 2
Q31: Disagree 1 2
Q31: Disagree a little 1 2
Q31: Agree a little 9 6
Q31: Agree 16 14
Q31: Strongly agree 20 21
Q32: Strongly disagree 6 3
Q32: Disagree 6 4
Q32: Disagree a little 8 7
Q32: Agree a little 12 12
Q32: Agree 12 12
Q32: Strongly agree 9 9
Q33: Strongly disagree 6 1
Q33: Disagree 6 5
Q33: Disagree a little 6 4
Q33: Agree a little 13 10
Q33: Agree 15 17
Q33: Strongly agree 7 10
Q34: Strongly disagree 10 2
Q34: Disagree 8 10
Q34: Disagree a little 10 7
Q34: Agree a little 15 7
Q34: Agree 7 11
Q34: Strongly agree 3 10
Q35: Strongly disagree 10 4
Q35: Disagree 9 8
Q35: Disagree a little 7 4
Q35: Agree a little 13 5
Q35: Agree 6 10
Q35: Strongly agree 8 16
Q36: Never in the last week 38 22
Q36: One or two days 5 4
Q36: Most days 4 7
Q36: Every day 2 2
Q36: A few times every day 1 5
Q36: Many times every day 3 7
Q37: Never in the last week 20 11
Q37: One or two days 10 9
Q37: Most days 9 8
Q37: Every day 9 9
Q37: A few times every day 2 2
Q37: Many times every day 3 8
Q38: Never in the last week 31 19
Q38: One or two days 10 3
Q38: Most days 3 7
Q38: Every day 7 6
Q38: A few times every day 0 2
Q38: Many times every day 2 10
Q39: Never in the last week 23 7
Q39: One or two days 6 11
Q39: Most days 7 6
Q39: Every day 8 6
Q39: A few times every day 2 2
Q39: Many times every day 7 15
30.Secondary Outcome
Title Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8
Hide Description 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 ?
Time Frame Prior to treatment on Day 8
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Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Number of participants
Q40: Strongly disagree 6 8
Q40: Disagree 12 6
Q40: Disagree a little 3 4
Q40: Agree a little 15 11
Q40: Agree 11 11
Q40: Strongly agree 6 7
Q41: Strongly disagree 9 12
Q41: Disagree 20 9
Q41: Disagree a little 6 5
Q41: Agree a little 10 6
Q41: Agree 6 7
Q41: Strongly agree 2 8
Q42: Strongly disagree 10 9
Q42: Disagree 14 9
Q42: Disagree a little 8 6
Q42: Agree a little 10 8
Q42: Agree 5 8
Q42: Strongly agree 6 7
Q43: Strongly disagree 3 3
Q43: Disagree 4 1
Q43: Disagree a little 3 0
Q43: Agree a little 12 9
Q43: Agree 17 18
Q43: Strongly agree 14 16
Q44: Strongly disagree 3 4
Q44: Disagree 8 3
Q44: Disagree a little 9 4
Q44: Agree a little 8 13
Q44: Agree 18 16
Q44: Strongly agree 7 7
Q45: Strongly disagree 10 6
Q45: Disagree 16 12
Q45: Disagree a little 9 7
Q45: Agree a little 12 10
Q45: Agree 4 7
Q45: Strongly agree 2 5
Q46: Excellent 5 3
Q46: Very Good 20 14
Q46: Good 11 12
Q46: Fair 16 14
Q46: Poor 1 4
QM1: Strongly disagree 5 6
QM1: Disagree 15 5
QM1: Disagree a little 2 2
QM1: Agree a little 18 14
QM1: Agree 11 16
QM1: Strongly agree 2 4
QM2: Strongly disagree 7 10
QM2: Disagree 14 7
QM2: Disagree a little 6 5
QM2: Agree a little 18 9
QM2: Agree 8 13
QM2: Strongly agree 0 3
QM3: Strongly disagree 12 11
QM3: Disagree 17 10
QM3: Disagree a little 9 8
QM3: Agree a little 12 8
QM3: Agree 3 8
QM3: Strongly agree 0 2
QM4: Strongly disagree 8 3
QM4: Disagree 15 9
QM4: Disagree a little 8 5
QM4: Agree a little 17 12
QM4: Agree 4 14
QM4: Strongly agree 1 4
QM5: Strongly disagree 9 3
QM5: Disagree 14 10
QM5: Disagree a little 9 7
QM5: Agree a little 15 11
QM5: Agree 5 12
QM5: Strongly agree 1 4
QM6: Strongly disagree 5 4
QM6: Disagree 7 2
QM6: Disagree a little 6 1
QM6: Agree a little 23 16
QM6: Agree 9 13
QM6: Strongly agree 3 11
QM7: Strongly disagree 5 3
QM7: Disagree 10 1
QM7: Disagree a little 4 3
QM7: Agree a little 18 12
QM7: Agree 11 21
QM7: Strongly agree 5 7
QM8: Strongly disagree 7 3
QM8: Disagree 10 3
QM8: Disagree a little 7 4
QM8: Agree a little 15 11
QM8: Agree 12 21
QM8: Strongly agree 2 5
QM9: Strongly disagree 7 5
QM9: Disagree 16 4
QM9: Disagree a little 7 6
QM9: Agree a little 14 16
QM9: Agree 7 15
QM9: Strongly agree 2 1
31.Secondary Outcome
Title Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8
Hide Description 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
Time Frame Day 1, Day 3, Day 8
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Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Day 1: Q1 4.60  (0.158) 4.81  (0.168)
Day 3: Q1 4.64  (0.161) 4.53  (0.171)
Day 8: Q1 4.75  (0.155) 4.72  (0.164)
Day 1: Q2 3.77  (0.172) 3.54  (0.183)
Day 3: Q2 3.67  (0.164) 3.09  (0.174)
Day 8: Q2 3.70  (0.167) 3.53  (0.177)
Day 1: Q3 5.21  (0.174) 5.76  (0.184)
Day 3: Q3 5.32  (0.158) 5.86  (0.167)
Day 8: Q3 5.24  (0.159) 5.81  (0.169)
Day 1: Q4 4.11  (0.152) 3.38  (0.161)
Day 3: Q4 3.93  (0.155) 3.21  (0.165)
Day 8: Q4 4.09  (0.150) 3.20  (0.159)
32.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame up to 13 days
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Hide Analysis Population Description
Analysis for this outcome was conducted on safety population which included all participants who were randomized and received at least one dose of study treatment during the study.
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description:
During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Number of participants
12 4
Time Frame up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Mouthwash Mineral Water
Hide Arm/Group Description During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day. During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
All-Cause Mortality
Experimental Mouthwash Mineral Water
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Mouthwash Mineral Water
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Experimental Mouthwash Mineral Water
Affected / at Risk (%) Affected / at Risk (%)
Total   12/53 (22.64%)   4/47 (8.51%) 
Gastrointestinal disorders     
ORAL DISCOMFORT  1/53 (1.89%)  0/47 (0.00%) 
PARAESTHESIA ORAL  2/53 (3.77%)  0/47 (0.00%) 
TONGUE COATED  1/53 (1.89%)  1/47 (2.13%) 
GLOSSODYNIA  1/53 (1.89%)  0/47 (0.00%) 
LIP DRY  1/53 (1.89%)  0/47 (0.00%) 
SENSITIVITY OF TEETH  1/53 (1.89%)  0/47 (0.00%) 
STOMATITIS  0/53 (0.00%)  1/47 (2.13%) 
Infections and infestations     
GASTROENTERITIS VIRAL  1/53 (1.89%)  0/47 (0.00%) 
HERPES SIMPLEX  0/53 (0.00%)  1/47 (2.13%) 
Injury, poisoning and procedural complications     
BURN ORAL CAVITY  1/53 (1.89%)  1/47 (2.13%) 
TONGUE INJURY  2/53 (3.77%)  0/47 (0.00%) 
LIP INJURY  1/53 (1.89%)  0/47 (0.00%) 
MOUTH INJURY  1/53 (1.89%)  0/47 (0.00%) 
TOOTH FRACTURE  1/53 (1.89%)  0/47 (0.00%) 
Musculoskeletal and connective tissue disorders     
SJOGREN'S SYNDROME  0/53 (0.00%)  1/47 (2.13%) 
Respiratory, thoracic and mediastinal disorders     
THROAT IRRITATION  1/53 (1.89%)  0/47 (0.00%) 
UPPER-AIRWAY COUGH SYNDROME  0/53 (0.00%)  1/47 (2.13%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02641912     History of Changes
Other Study ID Numbers: 204870
First Submitted: December 24, 2015
First Posted: December 30, 2015
Results First Submitted: November 30, 2016
Results First Posted: January 27, 2017
Last Update Posted: July 11, 2017