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A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water

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ClinicalTrials.gov Identifier: NCT03494985
Recruitment Status : Completed
First Posted : April 11, 2018
Results First Posted : July 18, 2018
Last Update Posted : September 26, 2018
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 Device: Experimental Oralbalance Moisturizing Gel
Device: Biotene Original Oral Rinse
Device: Biotene Moisturizing Mouth Spray
Other: Water
Enrollment 422
Recruitment Details Participants were recruited from 2 sites in United States of America.
Pre-assignment Details 467 participants were screened, out of which 45 were not randomized to the study. 15 did not meet study criteria, 8 were lost to follow-up, 19 withdrew their consent, and 3 were due to other reason (not specified). 422 were enrolled in the study out of which 26 did not meet eligibility criteria. Remaining 396 started the study.
Arm/Group Title OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Hide Arm/Group Description All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits. All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits. All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits. All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
Period Title: Overall Study
Started 101 98 98 99
Completed 96 92 92 94
Not Completed 5 6 6 5
Reason Not Completed
Adverse Event             3             2             3             0
Other (Withdrawal of consent)             2             3             2             5
Other (Not specified)             0             1             1             0
Arm/Group Title OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use Total
Hide Arm/Group Description All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits. All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits. All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits. All the participants in this arm used water as instructed under the supervision of trained site staff on their visits. Total of all reporting groups
Overall Number of Baseline Participants 101 98 98 99 396
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 98 participants 98 participants 99 participants 396 participants
56.2  (10.19) 52.6  (10.87) 54.0  (9.80) 52.7  (9.61) 53.9  (10.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 98 participants 98 participants 99 participants 396 participants
Female
73
  72.3%
74
  75.5%
79
  80.6%
78
  78.8%
304
  76.8%
Male
28
  27.7%
24
  24.5%
19
  19.4%
21
  21.2%
92
  23.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 98 participants 98 participants 99 participants 396 participants
Hispanic or Latino
6
   5.9%
11
  11.2%
7
   7.1%
16
  16.2%
40
  10.1%
Not Hispanic or Latino
95
  94.1%
87
  88.8%
91
  92.9%
83
  83.8%
356
  89.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 98 participants 98 participants 99 participants 396 participants
American Indian or Alaska Native
0
   0.0%
2
   2.0%
0
   0.0%
0
   0.0%
2
   0.5%
Asian
2
   2.0%
1
   1.0%
2
   2.0%
2
   2.0%
7
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  12.9%
17
  17.3%
16
  16.3%
13
  13.1%
59
  14.9%
White
85
  84.2%
77
  78.6%
80
  81.6%
84
  84.8%
326
  82.3%
More than one race
1
   1.0%
1
   1.0%
0
   0.0%
0
   0.0%
2
   0.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)
Hide Description Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 2 hours after supervised product use on Day 29 of treatment.
Time Frame At Day 29 of treatment (2 hours after supervised product use)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT, N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment. Number of participants analyzed for this endpoint were part of the IIT population, evaluated on Day 29.
Arm/Group Title OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Hide Arm/Group Description:
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
Overall Number of Participants Analyzed 95 92 91 92
Mean (Standard Deviation)
Unit of Measure: Score on scale
2.7  (1.07) 2.9  (0.99) 2.6  (1.02) 2.0  (0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OralBalance Moisturizing Gel, Water Only Use
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value was adjusted using Dunnett's method for multiple comparisons
Method ANOVA
Comments ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.4 to 0.9
Estimation Comments First named treatment minus second named treatment such that a positive value favours the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Rinse, Water Only Use
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value was adjusted using Dunnett's method for multiple comparisons
Method ANOVA
Comments ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.6 to 1.2
Estimation Comments First named treatment minus second named treatment such that a positive value favours the first named treatment.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Moisturizing Mouth Spray, Water Only Use
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value was adjusted using Dunnett's method for multiple comparisons.
Method ANOVA
Comments ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.3 to 0.9
Estimation Comments First named treatment minus second named treatment such that a positive value favours the first named treatment.
2.Secondary Outcome
Title Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29
Hide Description Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product:1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 30 minutes, 1 hour, and 4 hours after supervised product use on Day 29 of treatment.
Time Frame At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.
Arm/Group Title OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Hide Arm/Group Description:
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
Overall Number of Participants Analyzed 101 98 98 99
Mean (Standard Deviation)
Unit of Measure: Score on scale
At 30 mins Number Analyzed 94 participants 92 participants 91 participants 92 participants
3.0  (0.94) 3.2  (0.86) 3.1  (1.00) 2.3  (0.97)
At 1 hour Number Analyzed 93 participants 92 participants 91 participants 92 participants
2.9  (0.97) 3.2  (0.82) 2.9  (0.97) 2.2  (0.95)
At 4 hours Number Analyzed 95 participants 92 participants 90 participants 93 participants
2.5  (1.11) 2.7  (1.03) 2.5  (1.02) 1.9  (0.95)
3.Secondary Outcome
Title Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1
Hide Description Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 30 minutes, 1 hour, 2, and 4 hours after supervised product use on Day 1 of treatment.
Time Frame At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.
Arm/Group Title OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Hide Arm/Group Description:
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
Overall Number of Participants Analyzed 101 98 98 99
Mean (Standard Deviation)
Unit of Measure: Score on scale
At 30 minutes Number Analyzed 96 participants 94 participants 95 participants 94 participants
2.8  (0.97) 2.8  (0.81) 2.7  (0.97) 2.2  (0.97)
At 1 hour Number Analyzed 98 participants 96 participants 93 participants 94 participants
2.8  (0.89) 2.7  (0.81) 2.7  (0.95) 2.0  (0.94)
At 2 hours Number Analyzed 98 participants 98 participants 94 participants 94 participants
2.6  (0.97) 2.4  (0.89) 2.5  (0.97) 1.8  (0.86)
At 4 hours Number Analyzed 97 participants 97 participants 95 participants 96 participants
2.4  (1.09) 2.3  (1.06) 2.3  (1.02) 1.6  (0.88)
4.Secondary Outcome
Title Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Hide Description Participants were asked to use the following scale to rate question (Q) 2 to 12 of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I had following questions 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 cooling sensation. PPAQ I was assessed at 30 minutes, 1 hour, 2, and 4 hours after supervised product use on Day 1 and 29 of treatment. Individual score for each question at different tome point was reported for this endpoint.
Time Frame At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT(N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.
Arm/Group Title OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Hide Arm/Group Description:
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
Overall Number of Participants Analyzed 101 98 98 99
Mean (Standard Deviation)
Unit of Measure: Score on scale
Q2 at Day 1, 30 minutes Number Analyzed 99 participants 96 participants 97 participants 98 participants
3.1  (0.92) 3.0  (0.79) 2.9  (1.00) 2.5  (1.10)
Q2 at Day 1, 1 hour Number Analyzed 98 participants 97 participants 98 participants 97 participants
2.9  (0.93) 2.8  (0.82) 2.8  (1.00) 2.2  (1.03)
Q2 at Day 1, 2 hours Number Analyzed 98 participants 98 participants 98 participants 96 participants
2.7  (0.97) 2.5  (0.93) 2.6  (0.99) 2.0  (0.95)
Q2 at Day 1, 4 hours Number Analyzed 98 participants 98 participants 97 participants 97 participants
2.4  (1.09) 2.4  (1.05) 2.4  (1.03) 1.8  (0.94)
Q2 at Day 29, 30 minutes Number Analyzed 96 participants 92 participants 93 participants 93 participants
3.0  (1.00) 3.3  (0.85) 3.2  (1.07) 2.4  (0.97)
Q2 at Day 29, 1 hour Number Analyzed 95 participants 92 participants 92 participants 93 participants
3.0  (0.87) 3.2  (0.85) 3.0  (1.00) 2.3  (1.03)
Q2 at Day 29. 2 hours Number Analyzed 96 participants 92 participants 92 participants 91 participants
2.7  (1.04) 3.0  (0.93) 2.8  (0.99) 2.2  (1.01)
Q2 at Day 29, 4 hours Number Analyzed 96 participants 92 participants 91 participants 92 participants
2.7  (1.06) 2.8  (1.00) 2.6  (1.07) 2.0  (0.99)
Q3 at Day 1, 30 minutes Number Analyzed 99 participants 97 participants 96 participants 95 participants
3.1  (0.97) 3.0  (0.82) 2.8  (1.02) 2.3  (1.05)
Q3 at Day 1, 1 hour Number Analyzed 98 participants 97 participants 96 participants 95 participants
2.8  (1.01) 2.7  (0.78) 2.7  (0.93) 2.1  (1.07)
Q3 at Day 1, 2 hours Number Analyzed 98 participants 97 participants 96 participants 93 participants
2.6  (1.00) 2.4  (0.91) 2.5  (0.98) 1.9  (0.93)
Q3 at Day 1, 4 hours Number Analyzed 95 participants 97 participants 96 participants 94 participants
2.3  (1.11) 2.2  (1.00) 2.3  (1.05) 1.6  (0.86)
Q3 at Day 29, 30 minutes Number Analyzed 96 participants 92 participants 92 participants 92 participants
3.0  (0.98) 3.3  (0.87) 3.1  (1.02) 2.3  (0.99)
Q3 at Day 29, 1 hour Number Analyzed 96 participants 92 participants 92 participants 91 participants
2.8  (1.01) 3.2  (0.86) 3.0  (1.04) 2.2  (1.01)
Q3 at Day 29. 2 hours Number Analyzed 96 participants 92 participants 92 participants 92 participants
2.7  (1.08) 2.9  (0.97) 2.7  (1.06) 2.0  (1.02)
Q3 at Day 29, 4 hours Number Analyzed 96 participants 92 participants 91 participants 90 participants
2.6  (1.04) 2.6  (1.01) 2.5  (1.08) 2.0  (1.05)
Q4 at Day 1, 30 minutes Number Analyzed 93 participants 94 participants 94 participants 89 participants
3.6  (0.88) 3.4  (0.83) 3.4  (0.94) 3.0  (1.12)
Q4 at Day 1, 1 hour Number Analyzed 91 participants 90 participants 94 participants 85 participants
3.3  (0.95) 3.2  (0.75) 3.1  (0.95) 2.6  (1.05)
Q4 at Day 1, 2 hours Number Analyzed 91 participants 90 participants 94 participants 88 participants
3.1  (0.93) 2.9  (0.83) 2.9  (0.88) 2.4  (1.00)
Q4 at Day 1, 4 hours Number Analyzed 88 participants 90 participants 94 participants 88 participants
2.9  (0.91) 2.8  (0.92) 2.8  (1.00) 2.3  (0.99)
Q4 at Day 29, 30 minutes Number Analyzed 88 participants 86 participants 91 participants 88 participants
3.3  (0.81) 3.5  (0.84) 3.4  (0.97) 2.7  (1.02)
Q4 at Day 29, 1 hour Number Analyzed 86 participants 85 participants 91 participants 84 participants
3.2  (0.87) 3.4  (0.78) 3.2  (0.95) 2.6  (0.99)
Q4 at Day 29. 2 hours Number Analyzed 86 participants 85 participants 89 participants 85 participants
3.1  (0.91) 3.3  (0.87) 3.0  (1.02) 2.5  (0.97)
Q4 at Day 29, 4 hours Number Analyzed 87 participants 85 participants 89 participants 86 participants
3.0  (1.02) 3.0  (0.90) 2.7  (1.01) 2.3  (1.04)
Q5 at Day 1, 30 minutes Number Analyzed 101 participants 97 participants 97 participants 96 participants
3.1  (1.08) 3.0  (0.92) 3.0  (1.13) 2.5  (1.13)
Q5 at Day 1, 1 hour Number Analyzed 99 participants 97 participants 96 participants 96 participants
2.8  (1.00) 2.8  (0.83) 2.9  (1.08) 2.1  (1.11)
Q5 at Day 1, 2 hours Number Analyzed 98 participants 98 participants 97 participants 96 participants
2.6  (1.07) 2.4  (0.93) 2.5  (1.02) 1.9  (1.06)
Q5 at Day 1, 4 hours Number Analyzed 97 participants 98 participants 97 participants 96 participants
2.3  (1.10) 2.2  (1.04) 2.2  (1.10) 1.6  (0.91)
Q5 at Day 29, 30 minutes Number Analyzed 95 participants 92 participants 92 participants 90 participants
3.1  (0.95) 3.3  (0.93) 3.1  (1.03) 2.4  (1.00)
Q5 at Day 29, 1 hour Number Analyzed 95 participants 92 participants 92 participants 91 participants
2.9  (1.09) 3.1  (0.92) 2.9  (1.04) 2.2  (1.06)
Q5 at Day 29. 2 hours Number Analyzed 95 participants 92 participants 92 participants 92 participants
2.7  (1.06) 2.9  (0.94) 2.7  (1.10) 2.1  (1.00)
Q5 at Day 29, 4 hours Number Analyzed 95 participants 92 participants 91 participants 91 participants
2.6  (1.10) 2.6  (0.98) 2.4  (1.09) 2.0  (1.00)
Q6 at Day 1, 30 minutes Number Analyzed 100 participants 97 participants 97 participants 96 participants
3.1  (1.06) 3.0  (0.86) 2.9  (1.12) 2.4  (1.18)
Q6 at Day 1, 1 hour Number Analyzed 98 participants 98 participants 96 participants 94 participants
2.8  (1.06) 2.7  (0.89) 2.8  (1.09) 2.0  (1.06)
Q6 at Day 1, 2 hours Number Analyzed 98 participants 97 participants 97 participants 95 participants
2.6  (1.02) 2.4  (0.94) 2.4  (1.05) 1.8  (0.98)
Q6 at Day 1, 4 hours Number Analyzed 97 participants 97 participants 97 participants 96 participants
2.2  (1.08) 2.2  (1.05) 2.1  (1.07) 1.6  (0.86)
Q6 at Day 29, 30 minutes Number Analyzed 95 participants 91 participants 93 participants 91 participants
3.1  (1.01) 3.3  (0.92) 3.1  (1.07) 2.3  (1.04)
Q6 at Day 29, 1 hour Number Analyzed 96 participants 91 participants 92 participants 90 participants
2.9  (1.09) 3.0  (0.94) 3.0  (1.04) 2.2  (1.04)
Q6 at Day 29. 2 hours Number Analyzed 95 participants 91 participants 92 participants 92 participants
2.7  (1.08) 2.9  (0.94) 2.7  (1.10) 2.0  (0.99)
Q6 at Day 29, 4 hours Number Analyzed 96 participants 91 participants 91 participants 90 participants
2.6  (1.14) 2.5  (0.97) 2.4  (1.09) 2.0  (0.98)
Q7 at Day 1, 30 minutes Number Analyzed 93 participants 95 participants 93 participants 81 participants
2.8  (1.02) 3.3  (0.92) 3.2  (1.10) 1.8  (1.06)
Q7 at Day 1, 1 hour Number Analyzed 88 participants 95 participants 93 participants 74 participants
2.5  (0.99) 2.9  (0.80) 2.7  (1.02) 1.7  (1.06)
Q7 at Day 1, 2 hours Number Analyzed 87 participants 95 participants 90 participants 70 participants
2.4  (1.12) 2.4  (0.85) 2.4  (1.04) 1.6  (0.91)
Q7 at Day 1, 4 hours Number Analyzed 85 participants 95 participants 90 participants 72 participants
2.1  (1.02) 2.2  (0.98) 2.1  (1.06) 1.5  (0.89)
Q7 at Day 29, 30 minutes Number Analyzed 85 participants 88 participants 91 participants 79 participants
2.8  (1.12) 3.2  (0.84) 3.0  (1.16) 2.0  (1.04)
Q7 at Day 29, 1 hour Number Analyzed 84 participants 89 participants 90 participants 79 participants
2.7  (1.19) 3.0  (0.89) 2.7  (1.08) 1.9  (1.03)
Q7 at Day 29. 2 hours Number Analyzed 83 participants 88 participants 90 participants 78 participants
2.5  (1.18) 2.7  (1.03) 2.4  (1.13) 1.8  (0.98)
Q7 at Day 29. 4 hours Number Analyzed 83 participants 88 participants 90 participants 79 participants
2.4  (1.20) 2.5  (1.11) 2.2  (1.12) 1.7  (0.91)
Q8 at Day 1, 30 minutes Number Analyzed 99 participants 94 participants 94 participants 97 participants
2.8  (0.99) 3.0  (0.92) 2.9  (1.18) 2.2  (1.12)
Q8 at Day 1, 1 hour Number Analyzed 98 participants 97 participants 95 participants 96 participants
2.8  (1.00) 2.7  (0.88) 2.6  (1.01) 2.0  (1.08)
Q8 at Day 1, 2 hours Number Analyzed 98 participants 95 participants 96 participants 95 participants
2.5  (1.13) 2.3  (0.93) 2.4  (0.97) 1.7  (0.90)
Q8 at Day 1, 4 hours Number Analyzed 97 participants 96 participants 96 participants 97 participants
2.2  (1.07) 2.2  (1.06) 2.2  (1.04) 1.6  (0.94)
Q8 at Day 29, 30 minutes Number Analyzed 95 participants 92 participants 92 participants 91 participants
3.0  (1.00) 3.3  (0.95) 3.0  (1.09) 2.2  (0.98)
Q8 at Day 29, 1 hour Number Analyzed 95 participants 91 participants 92 participants 92 participants
2.9  (1.05) 3.1  (0.94) 2.8  (1.11) 2.1  (1.03)
Q8 at Day 29. 2 hours Number Analyzed 95 participants 92 participants 92 participants 92 participants
2.6  (1.04) 2.9  (0.99) 2.6  (1.06) 2.0  (0.97)
Q8 at Day 29. 4 hours Number Analyzed 95 participants 91 participants 91 participants 92 participants
2.5  (1.09) 2.6  (1.02) 2.3  (1.13) 2.0  (1.02)
Q9 at Day 1, 30 minutes Number Analyzed 100 participants 97 participants 96 participants 95 participants
3.0  (0.96) 3.1  (0.84) 2.9  (1.13) 2.3  (1.10)
Q9 at Day 1, 1 hour Number Analyzed 97 participants 94 participants 96 participants 95 participants
2.8  (0.92) 2.8  (0.80) 2.7  (1.01) 2.1  (1.04)
Q9 at Day 1, 2 hours Number Analyzed 98 participants 97 participants 95 participants 96 participants
2.6  (1.01) 2.5  (0.87) 2.5  (1.00) 1.9  (0.95)
Q9 at Day 1, 4 hours Number Analyzed 97 participants 94 participants 95 participants 97 participants
2.4  (1.11) 2.3  (1.04) 2.2  (0.98) 1.7  (0.85)
Q9 at Day 29, 30 minutes Number Analyzed 96 participants 92 participants 92 participants 91 participants
3.0  (1.05) 3.3  (0.90) 3.1  (1.03) 2.3  (1.03)
Q9 at Day 29, 1 hour Number Analyzed 95 participants 92 participants 92 participants 92 participants
2.9  (1.03) 3.1  (0.90) 3.0  (1.02) 2.3  (1.01)
Q9 at Day 29. 2 hours Number Analyzed 95 participants 92 participants 92 participants 92 participants
2.6  (1.07) 2.9  (0.93) 2.7  (1.07) 2.0  (0.98)
Q9 at Day 29. 4 hours Number Analyzed 95 participants 92 participants 91 participants 92 participants
2.6  (1.11) 2.7  (0.96) 2.4  (1.07) 2.0  (1.01)
Q10 at Day 1, 30 minutes Number Analyzed 92 participants 89 participants 94 participants 92 participants
3.1  (0.95) 3.2  (0.85) 3.1  (1.07) 2.6  (1.18)
Q10 at Day 1, 1 hour Number Analyzed 89 participants 89 participants 94 participants 96 participants
2.9  (0.92) 3.0  (0.74) 3.0  (0.96) 2.3  (1.03)
Q10 at Day 1, 2 hours Number Analyzed 90 participants 90 participants 93 participants 94 participants
2.8  (1.05) 2.7  (0.86) 2.7  (0.93) 2.2  (1.00)
Q10 at Day 1, 4 hours Number Analyzed 87 participants 90 participants 93 participants 94 participants
2.8  (0.99) 2.6  (1.05) 2.5  (1.08) 2.1  (1.05)
Q10 at Day 29, 30 minutes Number Analyzed 87 participants 85 participants 91 participants 89 participants
3.2  (0.92) 3.5  (0.81) 3.2  (1.02) 2.4  (0.99)
Q10 at Day 29, 1 hour Number Analyzed 87 participants 85 participants 90 participants 88 participants
3.0  (1.01) 3.3  (0.79) 3.0  (0.99) 2.4  (0.94)
Q10 at Day 29. 2 hours Number Analyzed 85 participants 85 participants 91 participants 87 participants
2.9  (1.05) 3.1  (0.83) 2.8  (1.02) 2.3  (0.95)
Q10 at Day 29. 4 hours Number Analyzed 86 participants 84 participants 89 participants 89 participants
2.8  (1.08) 2.9  (0.92) 2.7  (1.03) 2.2  (1.02)
Q11 at Day 1, 30 minutes Number Analyzed 99 participants 96 participants 95 participants 97 participants
3.0  (0.91) 3.1  (0.94) 3.1  (1.08) 2.4  (1.18)
Q11 at Day 1, 1 hour Number Analyzed 98 participants 97 participants 96 participants 97 participants
2.8  (0.91) 2.9  (0.89) 2.8  (1.06) 2.2  (1.01)
Q11 at Day 1, 2 hours Number Analyzed 98 participants 97 participants 96 participants 98 participants
2.6  (1.01) 2.6  (0.92) 2.4  (0.98) 2.0  (1.02)
Q11 at Day 1, 4 hours Number Analyzed 95 participants 96 participants 96 participants 99 participants
2.5  (1.09) 2.4  (1.05) 2.3  (1.05) 1.9  (0.96)
Q11 at Day 29, 30 minutes Number Analyzed 95 participants 92 participants 92 participants 92 participants
3.1  (0.97) 3.3  (0.94) 3.2  (0.99) 2.4  (1.03)
Q11 at Day 29, 1 hour Number Analyzed 96 participants 92 participants 92 participants 91 participants
2.9  (0.92) 3.1  (0.90) 3.0  (0.98) 2.3  (1.01)
Q11 at Day 29, 2 hours Number Analyzed 95 participants 92 participants 92 participants 92 participants
2.7  (0.99) 2.9  (0.94) 2.7  (1.06) 2.1  (0.96)
Q11 at Day 29. 4 hours Number Analyzed 95 participants 92 participants 91 participants 91 participants
2.6  (1.05) 2.7  (0.94) 2.5  (1.09) 2.1  (0.97)
Q12 at Day 1, 30 minutes Number Analyzed 93 participants 93 participants 92 participants 84 participants
2.6  (1.16) 3.1  (1.01) 2.9  (1.21) 2.2  (1.25)
Q12 at Day 1, 1 hour Number Analyzed 88 participants 94 participants 90 participants 78 participants
2.3  (1.12) 2.7  (1.01) 2.5  (1.03) 2.0  (1.26)
Q12 at Day 1, 2 hours Number Analyzed 88 participants 94 participants 86 participants 76 participants
2.2  (1.07) 2.1  (0.91) 2.1  (0.99) 1.7  (0.94)
Q12 at Day 1, 4 hours Number Analyzed 87 participants 93 participants 85 participants 75 participants
1.9  (0.96) 2.0  (0.97) 2.0  (0.92) 1.6  (0.93)
Q12 at Day 29, 30 minutes Number Analyzed 84 participants 89 participants 88 participants 83 participants
2.8  (1.12) 3.1  (0.96) 2.9  (1.10) 2.1  (0.98)
Q12 at Day 29, 1 hour Number Analyzed 85 participants 88 participants 88 participants 80 participants
2.5  (1.11) 2.8  (0.97) 2.6  (1.11) 2.0  (0.95)
Q12 at Day 29. 2 hours Number Analyzed 86 participants 86 participants 86 participants 81 participants
2.3  (1.12) 2.6  (0.99) 2.3  (1.15) 1.7  (0.87)
Q12 at Day 29. 4 hours Number Analyzed 85 participants 87 participants 86 participants 80 participants
2.3  (1.18) 2.3  (1.06) 2.1  (1.07) 1.7  (0.91)
5.Secondary Outcome
Title Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Hide Description Participants were asked to use the following scale to rate questions of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQI had following questions 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 cooling sensation. PPAQ I was assessed at 2 hours after supervised product use on Day 8 of treatment.
Time Frame At Day 8 (2 hours after supervised product use)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.
Arm/Group Title OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Hide Arm/Group Description:
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
Overall Number of Participants Analyzed 101 98 98 99
Mean (Standard Deviation)
Unit of Measure: Score on scale
Q1 at Day 8, 2 hours Number Analyzed 97 participants 93 participants 95 participants 93 participants
2.8  (0.98) 3.0  (0.86) 2.9  (0.86) 2.1  (0.92)
Q2 at Day 8, 2 hours Number Analyzed 96 participants 93 participants 96 participants 94 participants
2.9  (0.97) 3.0  (0.79) 3.0  (1.00) 2.2  (0.98)
Q3 at Day 8, 2 hours Number Analyzed 96 participants 93 participants 94 participants 91 participants
2.8  (1.04) 2.9  (0.76) 2.8  (0.97) 2.0  (0.92)
Q4 at Day 8, 2 hours Number Analyzed 87 participants 87 participants 93 participants 89 participants
3.3  (0.89) 3.2  (0.75) 3.2  (0.97) 2.5  (1.00)
Q5 at Day 8, 2 hours Number Analyzed 96 participants 93 participants 94 participants 94 participants
2.8  (1.00) 3.0  (0.93) 2.9  (1.07) 2.1  (1.04)
Q6 at Day 8, 2 hours Number Analyzed 96 participants 93 participants 94 participants 90 participants
2.8  (0.98) 2.9  (0.90) 2.8  (1.11) 2.0  (1.09)
Q7 at Day 8, 2 hours Number Analyzed 85 participants 90 participants 93 participants 76 participants
2.6  (1.09) 2.9  (0.84) 2.6  (1.02) 1.5  (0.84)
Q8 at Day 8, 2 hours Number Analyzed 96 participants 93 participants 95 participants 94 participants
2.7  (1.00) 2.9  (0.90) 2.7  (1.07) 1.9  (0.94)
Q9 at Day 8, 2 hours Number Analyzed 97 participants 93 participants 95 participants 94 participants
2.8  (0.97) 2.9  (0.81) 2.8  (1.07) 2.1  (0.98)
Q10 at Day 8, 2 hours Number Analyzed 86 participants 86 participants 93 participants 88 participants
3.0  (0.92) 3.2  (0.77) 3.0  (0.99) 2.4  (1.01)
Q11 at Day 8, 2 hours Number Analyzed 96 participants 93 participants 94 participants 94 participants
2.9  (0.90) 3.0  (0.81) 2.8  (1.02) 2.1  (1.02)
Q12 at Day 8, 2 hours Number Analyzed 87 participants 90 participants 88 participants 81 participants
2.3  (1.10) 2.7  (0.84) 2.4  (1.03) 1.7  (0.91)
6.Secondary Outcome
Title Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Hide Description Participants were asked to use the following scale to rate questions of PPAQ II as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ II had following questions; 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. PPAQ II was assessed before supervised product use on Day 8 and 29 of treatment.
Time Frame At Day 8 and 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.
Arm/Group Title OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Hide Arm/Group Description:
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
Overall Number of Participants Analyzed 101 98 98 99
Mean (Standard Deviation)
Unit of Measure: Score on scale
Q1 at Day 8 Number Analyzed 94 participants 91 participants 95 participants 90 participants
2.5  (0.96) 2.7  (0.93) 2.6  (1.00) 2.2  (0.91)
Q1 at Day 29 Number Analyzed 94 participants 88 participants 90 participants 84 participants
2.7  (1.11) 3.0  (0.93) 2.8  (1.18) 2.2  (1.08)
Q2 at Day 8 Number Analyzed 89 participants 82 participants 87 participants 88 participants
2.7  (0.95) 2.9  (0.83) 2.8  (0.94) 2.1  (0.95)
Q2 at Day 29 Number Analyzed 84 participants 82 participants 84 participants 86 participants
3.1  (1.06) 3.2  (0.96) 2.9  (1.18) 2.3  (1.20)
Q3 at Day 8 Number Analyzed 95 participants 91 participants 94 participants 92 participants
2.5  (0.94) 2.8  (0.90) 2.6  (0.99) 1.9  (1.02)
Q3 at Day 29 Number Analyzed 95 participants 91 participants 91 participants 88 participants
2.7  (1.09) 3.0  (1.08) 2.6  (1.18) 2.1  (1.12)
Q4 at Day 8 Number Analyzed 97 participants 93 participants 95 participants 94 participants
2.6  (0.97) 2.7  (0.89) 2.6  (0.98) 1.9  (0.90)
Q4 at Day 29 Number Analyzed 96 participants 90 participants 93 participants 88 participants
2.8  (1.15) 3.1  (1.07) 2.8  (1.07) 2.2  (1.08)
Q5 at Day 8 Number Analyzed 96 participants 93 participants 93 participants 90 participants
2.6  (0.98) 2.8  (0.93) 2.5  (1.00) 1.9  (0.91)
Q5 at Day 29 Number Analyzed 96 participants 90 participants 92 participants 88 participants
2.8  (1.11) 3.0  (1.06) 2.8  (1.11) 2.0  (1.06)
Q6 at Day 8 Number Analyzed 96 participants 93 participants 94 participants 90 participants
2.6  (1.00) 2.8  (0.94) 2.5  (0.92) 1.9  (1.00)
Q6 at Day 29 Number Analyzed 96 participants 90 participants 91 participants 85 participants
2.8  (1.15) 3.0  (1.08) 2.8  (1.12) 2.1  (1.11)
7.Secondary Outcome
Title Area Under Curve (AUC) up to 4 Hours After Treatment- Response of All Question of the Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Hide Description The AUC was calculated for the interval starting at the time of the 30 minute response and ending at the time of the last valid reading using the trapezoidal method on Day 1 and Day 29. AUC was calculated for the score of the individual question of PPAQ1. All the questions were scored using the following scale: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent.
Time Frame At Day 1 and 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.
Arm/Group Title OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Hide Arm/Group Description:
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
Overall Number of Participants Analyzed 101 98 98 99
Mean (Standard Deviation)
Unit of Measure: Scores on scale/seconds
Q1, AUC At Day 1 Number Analyzed 93 participants 94 participants 92 participants 90 participants
2.6  (0.88) 2.5  (0.79) 2.5  (0.85) 1.9  (0.79)
Q1, AUC At Day 29 Number Analyzed 93 participants 92 participants 90 participants 92 participants
2.7  (0.96) 2.9  (0.88) 2.7  (0.93) 2.0  (0.89)
Q2, AUC At Day 1 Number Analyzed 95 participants 96 participants 96 participants 95 participants
2.7  (0.88) 2.6  (0.80) 2.6  (0.83) 2.0  (0.87)
Q2, AUC At Day 29 Number Analyzed 95 participants 92 participants 91 participants 91 participants
2.8  (0.93) 3.0  (0.85) 2.8  (0.92) 2.2  (0.95)
Q3, AUC At Day 1 Number Analyzed 94 participants 97 participants 95 participants 91 participants
2.6  (0.93) 2.5  (0.75) 2.5  (0.86) 1.9  (0.85)
Q3, AUC At Day 29 Number Analyzed 96 participants 92 participants 91 participants 90 participants
2.7  (0.97) 2.9  (0.86) 2.7  (0.94) 2.1  (0.96)
Q4, AUC At Day 1 Number Analyzed 87 participants 90 participants 91 participants 81 participants
3.1  (0.78) 3.0  (0.73) 2.9  (0.78) 2.5  (0.95)
Q4, AUC At Day 29 Number Analyzed 85 participants 85 participants 87 participants 83 participants
3.1  (0.85) 3.2  (0.79) 3.0  (0.88) 2.5  (0.95)
Q5, AUC At Day 1 Number Analyzed 96 participants 97 participants 96 participants 94 participants
2.6  (0.94) 2.5  (0.79) 2.5  (0.93) 1.9  (0.91)
Q5, AUC At Day 29 Number Analyzed 94 participants 92 participants 91 participants 90 participants
2.7  (0.99) 2.9  (0.86) 2.7  (0.98) 2.1  (0.95)
Q6, AUC At Day 1 Number Analyzed 95 participants 97 participants 96 participants 92 participants
2.6  (0.90) 2.4  (0.80) 2.5  (0.93) 1.8  (0.88)
Q6, AUC At Day 29 Number Analyzed 95 participants 91 participants 91 participants 88 participants
2.8  (1.01) 2.9  (0.86) 2.7  (0.98) 2.1  (0.93)
Q7, AUC At Day 1 Number Analyzed 81 participants 94 participants 86 participants 65 participants
2.4  (0.94) 2.5  (0.75) 2.5  (0.93) 1.6  (0.93)
Q7, AUC At Day 29 Number Analyzed 82 participants 87 participants 87 participants 73 participants
2.6  (1.10) 2.8  (0.92) 2.5  (1.03) 1.8  (0.94)
Q8, AUC At Day 1 Number Analyzed 95 participants 92 participants 92 participants 92 participants
2.5  (0.94) 2.4  (0.80) 2.4  (0.87) 1.8  (0.86)
Q8, AUC At Day 29 Number Analyzed 95 participants 91 participants 91 participants 91 participants
2.7  (0.98) 2.9  (0.89) 2.6  (0.98) 2.0  (0.94)
Q9, AUC At Day 1 Number Analyzed 95 participants 93 participants 94 participants 93 participants
2.6  (0.88) 2.6  (0.75) 2.5  (0.86) 1.9  (0.84)
Q9, AUC At Day 29 Number Analyzed 95 participants 92 participants 91 participants 91 participants
2.7  (1.00) 2.9  (0.84) 2.7  (0.96) 2.1  (0.93)
Q10, AUC At Day 1 Number Analyzed 86 participants 87 participants 91 participants 88 participants
2.8  (0.82) 2.7  (0.69) 2.7  (0.85) 2.2  (0.95)
Q10, AUC At Day 29 Number Analyzed 84 participants 84 participants 88 participants 86 participants
2.9  (0.96) 3.1  (0.77) 2.9  (0.91) 2.3  (0.93)
Q11, AUC At Day 1 Number Analyzed 93 participants 95 participants 95 participants 95 participants
2.6  (0.89) 2.6  (0.81) 2.5  (0.89) 2.0  (0.89)
Q11, AUC At Day 29 Number Analyzed 94 participants 92 participants 91 participants 91 participants
2.8  (0.92) 2.9  (0.85) 2.8  (0.95) 2.2  (0.92)
Q12, AUC At Day 1 Number Analyzed 82 participants 90 participants 78 participants 69 participants
2.2  (0.96) 2.3  (0.79) 2.2  (0.87) 1.8  (0.96)
Q12, AUC At Day 29 Number Analyzed 81 participants 85 participants 84 participants 78 participants
2.4  (1.06) 2.6  (0.90) 2.4  (1.01) 1.8  (0.86)
Time Frame Approximately 29 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Hide Arm/Group Description All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits. All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits. All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits. All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
All-Cause Mortality
OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/98 (0.00%)   0/98 (0.00%)   0/99 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   1/98 (1.02%)   2/98 (2.04%)   0/99 (0.00%) 
Cardiac disorders         
CARDIAC ARREST   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  0/99 (0.00%) 
Infections and infestations         
DIVERTICULITIS   0/101 (0.00%)  0/98 (0.00%)  1/98 (1.02%)  0/99 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
OVARIAN CANCER   0/101 (0.00%)  0/98 (0.00%)  1/98 (1.02%)  0/99 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
OralBalance Moisturizing Gel Oral Rinse Moisturizing Mouth Spray Water Only Use
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/101 (16.83%)   21/98 (21.43%)   12/98 (12.24%)   20/99 (20.20%) 
Gastrointestinal disorders         
PARAESTHESIA ORAL   1/101 (0.99%)  0/98 (0.00%)  0/98 (0.00%)  0/99 (0.00%) 
MOUTH HAEMORRHAGE   1/101 (0.99%)  0/98 (0.00%)  0/98 (0.00%)  0/99 (0.00%) 
LIP DRY   1/101 (0.99%)  0/98 (0.00%)  0/98 (0.00%)  0/99 (0.00%) 
CHEILITIS   1/101 (0.99%)  0/98 (0.00%)  0/98 (0.00%)  0/99 (0.00%) 
NAUSEA   1/101 (0.99%)  0/98 (0.00%)  1/98 (1.02%)  0/99 (0.00%) 
LIP EXFOLIATION   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  0/99 (0.00%) 
GINGIVAL PAIN   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  1/99 (1.01%) 
ABDOMINAL DISCOMFORT   0/101 (0.00%)  1/98 (1.02%)  1/98 (1.02%)  0/99 (0.00%) 
DRY MOUTH   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  0/99 (0.00%) 
GLOSSODYNIA   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  0/99 (0.00%) 
GINGIVAL INFLAMMATION   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  1/99 (1.01%) 
TONGUE COATED   1/101 (0.99%)  3/98 (3.06%)  2/98 (2.04%)  1/99 (1.01%) 
HYPOAESTHESIA ORAL   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  0/99 (0.00%) 
TONGUE DISORDER   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
ORAL MUCOSAL EXFOLIATION   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
GINGIVAL BLEEDING   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
LIP ULCERATION   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
TOOTHACHE   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
General disorders         
DEVICE EXPULSION   1/101 (0.99%)  0/98 (0.00%)  0/98 (0.00%)  0/99 (0.00%) 
APPLICATION SITE ANAESTHESIA   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  0/99 (0.00%) 
PAIN   0/101 (0.00%)  0/98 (0.00%)  1/98 (1.02%)  0/99 (0.00%) 
PRODUCT TASTE ABNORMAL   0/101 (0.00%)  0/98 (0.00%)  1/98 (1.02%)  0/99 (0.00%) 
APPLICATION SITE PAIN   0/101 (0.00%)  0/98 (0.00%)  1/98 (1.02%)  0/99 (0.00%) 
DEVICE FAILURE   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  2/99 (2.02%) 
Infections and infestations         
ORAL HERPES   2/101 (1.98%)  1/98 (1.02%)  0/98 (0.00%)  3/99 (3.03%) 
BRONCHITIS   1/101 (0.99%)  0/98 (0.00%)  0/98 (0.00%)  0/99 (0.00%) 
NASOPHARYNGITIS   0/101 (0.00%)  3/98 (3.06%)  1/98 (1.02%)  1/99 (1.01%) 
HORDEOLUM   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  0/99 (0.00%) 
TOOTH ABSCESS   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
LARYNGITIS   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
Injury, poisoning and procedural complications         
TRAUMATIC ULCER   3/101 (2.97%)  3/98 (3.06%)  0/98 (0.00%)  0/99 (0.00%) 
TOOTH FRACTURE   1/101 (0.99%)  0/98 (0.00%)  0/98 (0.00%)  2/99 (2.02%) 
Tongue Injury   1/101 (0.99%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
CONTUSION   0/101 (0.00%)  0/98 (0.00%)  1/98 (1.02%)  0/99 (0.00%) 
FALL   0/101 (0.00%)  0/98 (0.00%)  1/98 (1.02%)  0/99 (0.00%) 
MOUTH INJURY   0/101 (0.00%)  0/98 (0.00%)  1/98 (1.02%)  1/99 (1.01%) 
THERMAL BURN   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
LIP INJURY   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
Musculoskeletal and connective tissue disorders         
MUSCULOSKELETAL PAIN   0/101 (0.00%)  0/98 (0.00%)  0/98 (0.00%)  1/99 (1.01%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
BASAL CELL CARCINOMA   1/101 (0.99%)  0/98 (0.00%)  0/98 (0.00%)  0/99 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
THROAT TIGHTNESS   1/101 (0.99%)  0/98 (0.00%)  0/98 (0.00%)  0/99 (0.00%) 
COUGH   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  0/99 (0.00%) 
OROPHARYNGAL PAIN   0/101 (0.00%)  0/98 (0.00%)  1/98 (1.02%)  0/99 (0.00%) 
Vascular disorders         
HYPERTENSION   0/101 (0.00%)  1/98 (1.02%)  0/98 (0.00%)  0/99 (0.00%) 
Indicates events were collected by systematic assessment
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: NCT03494985     History of Changes
Other Study ID Numbers: 202902
RH01986 ( Other Identifier: GSK )
First Submitted: April 5, 2018
First Posted: April 11, 2018
Results First Submitted: June 25, 2018
Results First Posted: July 18, 2018
Last Update Posted: September 26, 2018