Trial Outcomes & Findings for A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water (NCT NCT03494985)
NCT ID: NCT03494985
Last Updated: 2018-09-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
422 participants
Primary outcome timeframe
At Day 29 of treatment (2 hours after supervised product use)
Results posted on
2018-09-26
Participant Flow
Participants were recruited from 2 sites in United States of America.
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.
Participant milestones
| Measure |
OralBalance Moisturizing Gel
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
98
|
98
|
99
|
|
Overall Study
COMPLETED
|
96
|
92
|
92
|
94
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
6
|
5
|
Reasons for withdrawal
| Measure |
OralBalance Moisturizing Gel
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
3
|
0
|
|
Overall Study
Other (Withdrawal of consent)
|
2
|
3
|
2
|
5
|
|
Overall Study
Other (Not specified)
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water
Baseline characteristics by cohort
| Measure |
OralBalance Moisturizing Gel
n=101 Participants
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
n=98 Participants
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
n=98 Participants
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
n=99 Participants
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.2 Years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
52.6 Years
STANDARD_DEVIATION 10.87 • n=7 Participants
|
54.0 Years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
52.7 Years
STANDARD_DEVIATION 9.61 • n=4 Participants
|
53.9 Years
STANDARD_DEVIATION 10.20 • n=21 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
304 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
356 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
326 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Day 29 of treatment (2 hours after supervised product use)Population: 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.
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.
Outcome measures
| Measure |
OralBalance Moisturizing Gel
n=95 Participants
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
n=92 Participants
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
n=91 Participants
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
n=92 Participants
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)
|
2.7 Score on scale
Standard Deviation 1.07
|
2.9 Score on scale
Standard Deviation 0.99
|
2.6 Score on scale
Standard Deviation 1.02
|
2.0 Score on scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use)Population: 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.
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.
Outcome measures
| Measure |
OralBalance Moisturizing Gel
n=101 Participants
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
n=98 Participants
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
n=98 Participants
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
n=99 Participants
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29
At 30 mins
|
3.0 Score on scale
Standard Deviation 0.94
|
3.2 Score on scale
Standard Deviation 0.86
|
3.1 Score on scale
Standard Deviation 1.00
|
2.3 Score on scale
Standard Deviation 0.97
|
|
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29
At 1 hour
|
2.9 Score on scale
Standard Deviation 0.97
|
3.2 Score on scale
Standard Deviation 0.82
|
2.9 Score on scale
Standard Deviation 0.97
|
2.2 Score on scale
Standard Deviation 0.95
|
|
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29
At 4 hours
|
2.5 Score on scale
Standard Deviation 1.11
|
2.7 Score on scale
Standard Deviation 1.03
|
2.5 Score on scale
Standard Deviation 1.02
|
1.9 Score on scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use)Population: 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.
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.
Outcome measures
| Measure |
OralBalance Moisturizing Gel
n=101 Participants
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
n=98 Participants
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
n=98 Participants
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
n=99 Participants
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1
At 2 hours
|
2.6 Score on scale
Standard Deviation 0.97
|
2.4 Score on scale
Standard Deviation 0.89
|
2.5 Score on scale
Standard Deviation 0.97
|
1.8 Score on scale
Standard Deviation 0.86
|
|
Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1
At 30 minutes
|
2.8 Score on scale
Standard Deviation 0.97
|
2.8 Score on scale
Standard Deviation 0.81
|
2.7 Score on scale
Standard Deviation 0.97
|
2.2 Score on scale
Standard Deviation 0.97
|
|
Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1
At 1 hour
|
2.8 Score on scale
Standard Deviation 0.89
|
2.7 Score on scale
Standard Deviation 0.81
|
2.7 Score on scale
Standard Deviation 0.95
|
2.0 Score on scale
Standard Deviation 0.94
|
|
Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1
At 4 hours
|
2.4 Score on scale
Standard Deviation 1.09
|
2.3 Score on scale
Standard Deviation 1.06
|
2.3 Score on scale
Standard Deviation 1.02
|
1.6 Score on scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use)Population: 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.
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.
Outcome measures
| Measure |
OralBalance Moisturizing Gel
n=101 Participants
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
n=98 Participants
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
n=98 Participants
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
n=99 Participants
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q4 at Day 1, 2 hours
|
3.1 Score on scale
Standard Deviation 0.93
|
2.9 Score on scale
Standard Deviation 0.83
|
2.9 Score on scale
Standard Deviation 0.88
|
2.4 Score on scale
Standard Deviation 1.00
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q2 at Day 1, 30 minutes
|
3.1 Score on scale
Standard Deviation 0.92
|
3.0 Score on scale
Standard Deviation 0.79
|
2.9 Score on scale
Standard Deviation 1.00
|
2.5 Score on scale
Standard Deviation 1.10
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q2 at Day 1, 1 hour
|
2.9 Score on scale
Standard Deviation 0.93
|
2.8 Score on scale
Standard Deviation 0.82
|
2.8 Score on scale
Standard Deviation 1.00
|
2.2 Score on scale
Standard Deviation 1.03
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q2 at Day 1, 2 hours
|
2.7 Score on scale
Standard Deviation 0.97
|
2.5 Score on scale
Standard Deviation 0.93
|
2.6 Score on scale
Standard Deviation 0.99
|
2.0 Score on scale
Standard Deviation 0.95
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q2 at Day 1, 4 hours
|
2.4 Score on scale
Standard Deviation 1.09
|
2.4 Score on scale
Standard Deviation 1.05
|
2.4 Score on scale
Standard Deviation 1.03
|
1.8 Score on scale
Standard Deviation 0.94
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q2 at Day 29, 30 minutes
|
3.0 Score on scale
Standard Deviation 1.00
|
3.3 Score on scale
Standard Deviation 0.85
|
3.2 Score on scale
Standard Deviation 1.07
|
2.4 Score on scale
Standard Deviation 0.97
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q2 at Day 29, 1 hour
|
3.0 Score on scale
Standard Deviation 0.87
|
3.2 Score on scale
Standard Deviation 0.85
|
3.0 Score on scale
Standard Deviation 1.00
|
2.3 Score on scale
Standard Deviation 1.03
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q2 at Day 29. 2 hours
|
2.7 Score on scale
Standard Deviation 1.04
|
3.0 Score on scale
Standard Deviation 0.93
|
2.8 Score on scale
Standard Deviation 0.99
|
2.2 Score on scale
Standard Deviation 1.01
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q2 at Day 29, 4 hours
|
2.7 Score on scale
Standard Deviation 1.06
|
2.8 Score on scale
Standard Deviation 1.00
|
2.6 Score on scale
Standard Deviation 1.07
|
2.0 Score on scale
Standard Deviation 0.99
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q3 at Day 1, 30 minutes
|
3.1 Score on scale
Standard Deviation 0.97
|
3.0 Score on scale
Standard Deviation 0.82
|
2.8 Score on scale
Standard Deviation 1.02
|
2.3 Score on scale
Standard Deviation 1.05
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q3 at Day 1, 1 hour
|
2.8 Score on scale
Standard Deviation 1.01
|
2.7 Score on scale
Standard Deviation 0.78
|
2.7 Score on scale
Standard Deviation 0.93
|
2.1 Score on scale
Standard Deviation 1.07
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q3 at Day 1, 2 hours
|
2.6 Score on scale
Standard Deviation 1.00
|
2.4 Score on scale
Standard Deviation 0.91
|
2.5 Score on scale
Standard Deviation 0.98
|
1.9 Score on scale
Standard Deviation 0.93
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q3 at Day 1, 4 hours
|
2.3 Score on scale
Standard Deviation 1.11
|
2.2 Score on scale
Standard Deviation 1.00
|
2.3 Score on scale
Standard Deviation 1.05
|
1.6 Score on scale
Standard Deviation 0.86
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q3 at Day 29, 30 minutes
|
3.0 Score on scale
Standard Deviation 0.98
|
3.3 Score on scale
Standard Deviation 0.87
|
3.1 Score on scale
Standard Deviation 1.02
|
2.3 Score on scale
Standard Deviation 0.99
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q3 at Day 29, 1 hour
|
2.8 Score on scale
Standard Deviation 1.01
|
3.2 Score on scale
Standard Deviation 0.86
|
3.0 Score on scale
Standard Deviation 1.04
|
2.2 Score on scale
Standard Deviation 1.01
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q3 at Day 29. 2 hours
|
2.7 Score on scale
Standard Deviation 1.08
|
2.9 Score on scale
Standard Deviation 0.97
|
2.7 Score on scale
Standard Deviation 1.06
|
2.0 Score on scale
Standard Deviation 1.02
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q3 at Day 29, 4 hours
|
2.6 Score on scale
Standard Deviation 1.04
|
2.6 Score on scale
Standard Deviation 1.01
|
2.5 Score on scale
Standard Deviation 1.08
|
2.0 Score on scale
Standard Deviation 1.05
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q4 at Day 1, 30 minutes
|
3.6 Score on scale
Standard Deviation 0.88
|
3.4 Score on scale
Standard Deviation 0.83
|
3.4 Score on scale
Standard Deviation 0.94
|
3.0 Score on scale
Standard Deviation 1.12
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q4 at Day 1, 1 hour
|
3.3 Score on scale
Standard Deviation 0.95
|
3.2 Score on scale
Standard Deviation 0.75
|
3.1 Score on scale
Standard Deviation 0.95
|
2.6 Score on scale
Standard Deviation 1.05
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q4 at Day 1, 4 hours
|
2.9 Score on scale
Standard Deviation 0.91
|
2.8 Score on scale
Standard Deviation 0.92
|
2.8 Score on scale
Standard Deviation 1.00
|
2.3 Score on scale
Standard Deviation 0.99
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q4 at Day 29, 30 minutes
|
3.3 Score on scale
Standard Deviation 0.81
|
3.5 Score on scale
Standard Deviation 0.84
|
3.4 Score on scale
Standard Deviation 0.97
|
2.7 Score on scale
Standard Deviation 1.02
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q5 at Day 29, 30 minutes
|
3.1 Score on scale
Standard Deviation 0.95
|
3.3 Score on scale
Standard Deviation 0.93
|
3.1 Score on scale
Standard Deviation 1.03
|
2.4 Score on scale
Standard Deviation 1.00
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q7 at Day 29. 2 hours
|
2.5 Score on scale
Standard Deviation 1.18
|
2.7 Score on scale
Standard Deviation 1.03
|
2.4 Score on scale
Standard Deviation 1.13
|
1.8 Score on scale
Standard Deviation 0.98
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q7 at Day 29. 4 hours
|
2.4 Score on scale
Standard Deviation 1.20
|
2.5 Score on scale
Standard Deviation 1.11
|
2.2 Score on scale
Standard Deviation 1.12
|
1.7 Score on scale
Standard Deviation 0.91
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q7 at Day 29, 30 minutes
|
2.8 Score on scale
Standard Deviation 1.12
|
3.2 Score on scale
Standard Deviation 0.84
|
3.0 Score on scale
Standard Deviation 1.16
|
2.0 Score on scale
Standard Deviation 1.04
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q7 at Day 29, 1 hour
|
2.7 Score on scale
Standard Deviation 1.19
|
3.0 Score on scale
Standard Deviation 0.89
|
2.7 Score on scale
Standard Deviation 1.08
|
1.9 Score on scale
Standard Deviation 1.03
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q8 at Day 1, 30 minutes
|
2.8 Score on scale
Standard Deviation 0.99
|
3.0 Score on scale
Standard Deviation 0.92
|
2.9 Score on scale
Standard Deviation 1.18
|
2.2 Score on scale
Standard Deviation 1.12
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q8 at Day 1, 1 hour
|
2.8 Score on scale
Standard Deviation 1.00
|
2.7 Score on scale
Standard Deviation 0.88
|
2.6 Score on scale
Standard Deviation 1.01
|
2.0 Score on scale
Standard Deviation 1.08
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q8 at Day 1, 2 hours
|
2.5 Score on scale
Standard Deviation 1.13
|
2.3 Score on scale
Standard Deviation 0.93
|
2.4 Score on scale
Standard Deviation 0.97
|
1.7 Score on scale
Standard Deviation 0.90
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q8 at Day 1, 4 hours
|
2.2 Score on scale
Standard Deviation 1.07
|
2.2 Score on scale
Standard Deviation 1.06
|
2.2 Score on scale
Standard Deviation 1.04
|
1.6 Score on scale
Standard Deviation 0.94
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q8 at Day 29, 30 minutes
|
3.0 Score on scale
Standard Deviation 1.00
|
3.3 Score on scale
Standard Deviation 0.95
|
3.0 Score on scale
Standard Deviation 1.09
|
2.2 Score on scale
Standard Deviation 0.98
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q8 at Day 29, 1 hour
|
2.9 Score on scale
Standard Deviation 1.05
|
3.1 Score on scale
Standard Deviation 0.94
|
2.8 Score on scale
Standard Deviation 1.11
|
2.1 Score on scale
Standard Deviation 1.03
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q8 at Day 29. 2 hours
|
2.6 Score on scale
Standard Deviation 1.04
|
2.9 Score on scale
Standard Deviation 0.99
|
2.6 Score on scale
Standard Deviation 1.06
|
2.0 Score on scale
Standard Deviation 0.97
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q8 at Day 29. 4 hours
|
2.5 Score on scale
Standard Deviation 1.09
|
2.6 Score on scale
Standard Deviation 1.02
|
2.3 Score on scale
Standard Deviation 1.13
|
2.0 Score on scale
Standard Deviation 1.02
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q9 at Day 1, 30 minutes
|
3.0 Score on scale
Standard Deviation 0.96
|
3.1 Score on scale
Standard Deviation 0.84
|
2.9 Score on scale
Standard Deviation 1.13
|
2.3 Score on scale
Standard Deviation 1.10
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q9 at Day 1, 1 hour
|
2.8 Score on scale
Standard Deviation 0.92
|
2.8 Score on scale
Standard Deviation 0.80
|
2.7 Score on scale
Standard Deviation 1.01
|
2.1 Score on scale
Standard Deviation 1.04
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q9 at Day 1, 2 hours
|
2.6 Score on scale
Standard Deviation 1.01
|
2.5 Score on scale
Standard Deviation 0.87
|
2.5 Score on scale
Standard Deviation 1.00
|
1.9 Score on scale
Standard Deviation 0.95
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q9 at Day 1, 4 hours
|
2.4 Score on scale
Standard Deviation 1.11
|
2.3 Score on scale
Standard Deviation 1.04
|
2.2 Score on scale
Standard Deviation 0.98
|
1.7 Score on scale
Standard Deviation 0.85
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q9 at Day 29, 30 minutes
|
3.0 Score on scale
Standard Deviation 1.05
|
3.3 Score on scale
Standard Deviation 0.90
|
3.1 Score on scale
Standard Deviation 1.03
|
2.3 Score on scale
Standard Deviation 1.03
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q9 at Day 29, 1 hour
|
2.9 Score on scale
Standard Deviation 1.03
|
3.1 Score on scale
Standard Deviation 0.90
|
3.0 Score on scale
Standard Deviation 1.02
|
2.3 Score on scale
Standard Deviation 1.01
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q9 at Day 29. 2 hours
|
2.6 Score on scale
Standard Deviation 1.07
|
2.9 Score on scale
Standard Deviation 0.93
|
2.7 Score on scale
Standard Deviation 1.07
|
2.0 Score on scale
Standard Deviation 0.98
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q9 at Day 29. 4 hours
|
2.6 Score on scale
Standard Deviation 1.11
|
2.7 Score on scale
Standard Deviation 0.96
|
2.4 Score on scale
Standard Deviation 1.07
|
2.0 Score on scale
Standard Deviation 1.01
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q10 at Day 1, 30 minutes
|
3.1 Score on scale
Standard Deviation 0.95
|
3.2 Score on scale
Standard Deviation 0.85
|
3.1 Score on scale
Standard Deviation 1.07
|
2.6 Score on scale
Standard Deviation 1.18
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q10 at Day 1, 1 hour
|
2.9 Score on scale
Standard Deviation 0.92
|
3.0 Score on scale
Standard Deviation 0.74
|
3.0 Score on scale
Standard Deviation 0.96
|
2.3 Score on scale
Standard Deviation 1.03
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q10 at Day 1, 2 hours
|
2.8 Score on scale
Standard Deviation 1.05
|
2.7 Score on scale
Standard Deviation 0.86
|
2.7 Score on scale
Standard Deviation 0.93
|
2.2 Score on scale
Standard Deviation 1.00
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q10 at Day 1, 4 hours
|
2.8 Score on scale
Standard Deviation 0.99
|
2.6 Score on scale
Standard Deviation 1.05
|
2.5 Score on scale
Standard Deviation 1.08
|
2.1 Score on scale
Standard Deviation 1.05
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q10 at Day 29, 30 minutes
|
3.2 Score on scale
Standard Deviation 0.92
|
3.5 Score on scale
Standard Deviation 0.81
|
3.2 Score on scale
Standard Deviation 1.02
|
2.4 Score on scale
Standard Deviation 0.99
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q10 at Day 29, 1 hour
|
3.0 Score on scale
Standard Deviation 1.01
|
3.3 Score on scale
Standard Deviation 0.79
|
3.0 Score on scale
Standard Deviation 0.99
|
2.4 Score on scale
Standard Deviation 0.94
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q10 at Day 29. 2 hours
|
2.9 Score on scale
Standard Deviation 1.05
|
3.1 Score on scale
Standard Deviation 0.83
|
2.8 Score on scale
Standard Deviation 1.02
|
2.3 Score on scale
Standard Deviation 0.95
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q10 at Day 29. 4 hours
|
2.8 Score on scale
Standard Deviation 1.08
|
2.9 Score on scale
Standard Deviation 0.92
|
2.7 Score on scale
Standard Deviation 1.03
|
2.2 Score on scale
Standard Deviation 1.02
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q11 at Day 1, 30 minutes
|
3.0 Score on scale
Standard Deviation 0.91
|
3.1 Score on scale
Standard Deviation 0.94
|
3.1 Score on scale
Standard Deviation 1.08
|
2.4 Score on scale
Standard Deviation 1.18
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q11 at Day 1, 1 hour
|
2.8 Score on scale
Standard Deviation 0.91
|
2.9 Score on scale
Standard Deviation 0.89
|
2.8 Score on scale
Standard Deviation 1.06
|
2.2 Score on scale
Standard Deviation 1.01
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q11 at Day 1, 2 hours
|
2.6 Score on scale
Standard Deviation 1.01
|
2.6 Score on scale
Standard Deviation 0.92
|
2.4 Score on scale
Standard Deviation 0.98
|
2.0 Score on scale
Standard Deviation 1.02
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q11 at Day 1, 4 hours
|
2.5 Score on scale
Standard Deviation 1.09
|
2.4 Score on scale
Standard Deviation 1.05
|
2.3 Score on scale
Standard Deviation 1.05
|
1.9 Score on scale
Standard Deviation 0.96
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q11 at Day 29, 30 minutes
|
3.1 Score on scale
Standard Deviation 0.97
|
3.3 Score on scale
Standard Deviation 0.94
|
3.2 Score on scale
Standard Deviation 0.99
|
2.4 Score on scale
Standard Deviation 1.03
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q11 at Day 29, 1 hour
|
2.9 Score on scale
Standard Deviation 0.92
|
3.1 Score on scale
Standard Deviation 0.90
|
3.0 Score on scale
Standard Deviation 0.98
|
2.3 Score on scale
Standard Deviation 1.01
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q11 at Day 29, 2 hours
|
2.7 Score on scale
Standard Deviation 0.99
|
2.9 Score on scale
Standard Deviation 0.94
|
2.7 Score on scale
Standard Deviation 1.06
|
2.1 Score on scale
Standard Deviation 0.96
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q11 at Day 29. 4 hours
|
2.6 Score on scale
Standard Deviation 1.05
|
2.7 Score on scale
Standard Deviation 0.94
|
2.5 Score on scale
Standard Deviation 1.09
|
2.1 Score on scale
Standard Deviation 0.97
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q12 at Day 1, 30 minutes
|
2.6 Score on scale
Standard Deviation 1.16
|
3.1 Score on scale
Standard Deviation 1.01
|
2.9 Score on scale
Standard Deviation 1.21
|
2.2 Score on scale
Standard Deviation 1.25
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q12 at Day 1, 1 hour
|
2.3 Score on scale
Standard Deviation 1.12
|
2.7 Score on scale
Standard Deviation 1.01
|
2.5 Score on scale
Standard Deviation 1.03
|
2.0 Score on scale
Standard Deviation 1.26
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q12 at Day 1, 2 hours
|
2.2 Score on scale
Standard Deviation 1.07
|
2.1 Score on scale
Standard Deviation 0.91
|
2.1 Score on scale
Standard Deviation 0.99
|
1.7 Score on scale
Standard Deviation 0.94
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q12 at Day 1, 4 hours
|
1.9 Score on scale
Standard Deviation 0.96
|
2.0 Score on scale
Standard Deviation 0.97
|
2.0 Score on scale
Standard Deviation 0.92
|
1.6 Score on scale
Standard Deviation 0.93
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q12 at Day 29, 30 minutes
|
2.8 Score on scale
Standard Deviation 1.12
|
3.1 Score on scale
Standard Deviation 0.96
|
2.9 Score on scale
Standard Deviation 1.10
|
2.1 Score on scale
Standard Deviation 0.98
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q12 at Day 29, 1 hour
|
2.5 Score on scale
Standard Deviation 1.11
|
2.8 Score on scale
Standard Deviation 0.97
|
2.6 Score on scale
Standard Deviation 1.11
|
2.0 Score on scale
Standard Deviation 0.95
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q12 at Day 29. 2 hours
|
2.3 Score on scale
Standard Deviation 1.12
|
2.6 Score on scale
Standard Deviation 0.99
|
2.3 Score on scale
Standard Deviation 1.15
|
1.7 Score on scale
Standard Deviation 0.87
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q12 at Day 29. 4 hours
|
2.3 Score on scale
Standard Deviation 1.18
|
2.3 Score on scale
Standard Deviation 1.06
|
2.1 Score on scale
Standard Deviation 1.07
|
1.7 Score on scale
Standard Deviation 0.91
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q4 at Day 29, 1 hour
|
3.2 Score on scale
Standard Deviation 0.87
|
3.4 Score on scale
Standard Deviation 0.78
|
3.2 Score on scale
Standard Deviation 0.95
|
2.6 Score on scale
Standard Deviation 0.99
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q4 at Day 29. 2 hours
|
3.1 Score on scale
Standard Deviation 0.91
|
3.3 Score on scale
Standard Deviation 0.87
|
3.0 Score on scale
Standard Deviation 1.02
|
2.5 Score on scale
Standard Deviation 0.97
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q4 at Day 29, 4 hours
|
3.0 Score on scale
Standard Deviation 1.02
|
3.0 Score on scale
Standard Deviation 0.90
|
2.7 Score on scale
Standard Deviation 1.01
|
2.3 Score on scale
Standard Deviation 1.04
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q5 at Day 1, 30 minutes
|
3.1 Score on scale
Standard Deviation 1.08
|
3.0 Score on scale
Standard Deviation 0.92
|
3.0 Score on scale
Standard Deviation 1.13
|
2.5 Score on scale
Standard Deviation 1.13
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q5 at Day 1, 1 hour
|
2.8 Score on scale
Standard Deviation 1.00
|
2.8 Score on scale
Standard Deviation 0.83
|
2.9 Score on scale
Standard Deviation 1.08
|
2.1 Score on scale
Standard Deviation 1.11
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q5 at Day 1, 2 hours
|
2.6 Score on scale
Standard Deviation 1.07
|
2.4 Score on scale
Standard Deviation 0.93
|
2.5 Score on scale
Standard Deviation 1.02
|
1.9 Score on scale
Standard Deviation 1.06
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q5 at Day 1, 4 hours
|
2.3 Score on scale
Standard Deviation 1.10
|
2.2 Score on scale
Standard Deviation 1.04
|
2.2 Score on scale
Standard Deviation 1.10
|
1.6 Score on scale
Standard Deviation 0.91
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q5 at Day 29, 1 hour
|
2.9 Score on scale
Standard Deviation 1.09
|
3.1 Score on scale
Standard Deviation 0.92
|
2.9 Score on scale
Standard Deviation 1.04
|
2.2 Score on scale
Standard Deviation 1.06
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q5 at Day 29. 2 hours
|
2.7 Score on scale
Standard Deviation 1.06
|
2.9 Score on scale
Standard Deviation 0.94
|
2.7 Score on scale
Standard Deviation 1.10
|
2.1 Score on scale
Standard Deviation 1.00
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q5 at Day 29, 4 hours
|
2.6 Score on scale
Standard Deviation 1.10
|
2.6 Score on scale
Standard Deviation 0.98
|
2.4 Score on scale
Standard Deviation 1.09
|
2.0 Score on scale
Standard Deviation 1.00
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q6 at Day 1, 30 minutes
|
3.1 Score on scale
Standard Deviation 1.06
|
3.0 Score on scale
Standard Deviation 0.86
|
2.9 Score on scale
Standard Deviation 1.12
|
2.4 Score on scale
Standard Deviation 1.18
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q6 at Day 1, 1 hour
|
2.8 Score on scale
Standard Deviation 1.06
|
2.7 Score on scale
Standard Deviation 0.89
|
2.8 Score on scale
Standard Deviation 1.09
|
2.0 Score on scale
Standard Deviation 1.06
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q6 at Day 1, 2 hours
|
2.6 Score on scale
Standard Deviation 1.02
|
2.4 Score on scale
Standard Deviation 0.94
|
2.4 Score on scale
Standard Deviation 1.05
|
1.8 Score on scale
Standard Deviation 0.98
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q6 at Day 1, 4 hours
|
2.2 Score on scale
Standard Deviation 1.08
|
2.2 Score on scale
Standard Deviation 1.05
|
2.1 Score on scale
Standard Deviation 1.07
|
1.6 Score on scale
Standard Deviation 0.86
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q6 at Day 29, 30 minutes
|
3.1 Score on scale
Standard Deviation 1.01
|
3.3 Score on scale
Standard Deviation 0.92
|
3.1 Score on scale
Standard Deviation 1.07
|
2.3 Score on scale
Standard Deviation 1.04
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q6 at Day 29, 1 hour
|
2.9 Score on scale
Standard Deviation 1.09
|
3.0 Score on scale
Standard Deviation 0.94
|
3.0 Score on scale
Standard Deviation 1.04
|
2.2 Score on scale
Standard Deviation 1.04
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q6 at Day 29. 2 hours
|
2.7 Score on scale
Standard Deviation 1.08
|
2.9 Score on scale
Standard Deviation 0.94
|
2.7 Score on scale
Standard Deviation 1.10
|
2.0 Score on scale
Standard Deviation 0.99
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q6 at Day 29, 4 hours
|
2.6 Score on scale
Standard Deviation 1.14
|
2.5 Score on scale
Standard Deviation 0.97
|
2.4 Score on scale
Standard Deviation 1.09
|
2.0 Score on scale
Standard Deviation 0.98
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q7 at Day 1, 30 minutes
|
2.8 Score on scale
Standard Deviation 1.02
|
3.3 Score on scale
Standard Deviation 0.92
|
3.2 Score on scale
Standard Deviation 1.10
|
1.8 Score on scale
Standard Deviation 1.06
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q7 at Day 1, 1 hour
|
2.5 Score on scale
Standard Deviation 0.99
|
2.9 Score on scale
Standard Deviation 0.80
|
2.7 Score on scale
Standard Deviation 1.02
|
1.7 Score on scale
Standard Deviation 1.06
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q7 at Day 1, 2 hours
|
2.4 Score on scale
Standard Deviation 1.12
|
2.4 Score on scale
Standard Deviation 0.85
|
2.4 Score on scale
Standard Deviation 1.04
|
1.6 Score on scale
Standard Deviation 0.91
|
|
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Q7 at Day 1, 4 hours
|
2.1 Score on scale
Standard Deviation 1.02
|
2.2 Score on scale
Standard Deviation 0.98
|
2.1 Score on scale
Standard Deviation 1.06
|
1.5 Score on scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: At Day 8 (2 hours after supervised product use)Population: 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.
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.
Outcome measures
| Measure |
OralBalance Moisturizing Gel
n=101 Participants
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
n=98 Participants
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
n=98 Participants
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
n=99 Participants
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q1 at Day 8, 2 hours
|
2.8 Score on scale
Standard Deviation 0.98
|
3.0 Score on scale
Standard Deviation 0.86
|
2.9 Score on scale
Standard Deviation 0.86
|
2.1 Score on scale
Standard Deviation 0.92
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q2 at Day 8, 2 hours
|
2.9 Score on scale
Standard Deviation 0.97
|
3.0 Score on scale
Standard Deviation 0.79
|
3.0 Score on scale
Standard Deviation 1.00
|
2.2 Score on scale
Standard Deviation 0.98
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q3 at Day 8, 2 hours
|
2.8 Score on scale
Standard Deviation 1.04
|
2.9 Score on scale
Standard Deviation 0.76
|
2.8 Score on scale
Standard Deviation 0.97
|
2.0 Score on scale
Standard Deviation 0.92
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q4 at Day 8, 2 hours
|
3.3 Score on scale
Standard Deviation 0.89
|
3.2 Score on scale
Standard Deviation 0.75
|
3.2 Score on scale
Standard Deviation 0.97
|
2.5 Score on scale
Standard Deviation 1.00
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q5 at Day 8, 2 hours
|
2.8 Score on scale
Standard Deviation 1.00
|
3.0 Score on scale
Standard Deviation 0.93
|
2.9 Score on scale
Standard Deviation 1.07
|
2.1 Score on scale
Standard Deviation 1.04
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q6 at Day 8, 2 hours
|
2.8 Score on scale
Standard Deviation 0.98
|
2.9 Score on scale
Standard Deviation 0.90
|
2.8 Score on scale
Standard Deviation 1.11
|
2.0 Score on scale
Standard Deviation 1.09
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q7 at Day 8, 2 hours
|
2.6 Score on scale
Standard Deviation 1.09
|
2.9 Score on scale
Standard Deviation 0.84
|
2.6 Score on scale
Standard Deviation 1.02
|
1.5 Score on scale
Standard Deviation 0.84
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q8 at Day 8, 2 hours
|
2.7 Score on scale
Standard Deviation 1.00
|
2.9 Score on scale
Standard Deviation 0.90
|
2.7 Score on scale
Standard Deviation 1.07
|
1.9 Score on scale
Standard Deviation 0.94
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q9 at Day 8, 2 hours
|
2.8 Score on scale
Standard Deviation 0.97
|
2.9 Score on scale
Standard Deviation 0.81
|
2.8 Score on scale
Standard Deviation 1.07
|
2.1 Score on scale
Standard Deviation 0.98
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q10 at Day 8, 2 hours
|
3.0 Score on scale
Standard Deviation 0.92
|
3.2 Score on scale
Standard Deviation 0.77
|
3.0 Score on scale
Standard Deviation 0.99
|
2.4 Score on scale
Standard Deviation 1.01
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q11 at Day 8, 2 hours
|
2.9 Score on scale
Standard Deviation 0.90
|
3.0 Score on scale
Standard Deviation 0.81
|
2.8 Score on scale
Standard Deviation 1.02
|
2.1 Score on scale
Standard Deviation 1.02
|
|
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Q12 at Day 8, 2 hours
|
2.3 Score on scale
Standard Deviation 1.10
|
2.7 Score on scale
Standard Deviation 0.84
|
2.4 Score on scale
Standard Deviation 1.03
|
1.7 Score on scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: At Day 8 and 29Population: 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.
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.
Outcome measures
| Measure |
OralBalance Moisturizing Gel
n=101 Participants
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
n=98 Participants
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
n=98 Participants
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
n=99 Participants
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q1 at Day 8
|
2.5 Score on scale
Standard Deviation 0.96
|
2.7 Score on scale
Standard Deviation 0.93
|
2.6 Score on scale
Standard Deviation 1.00
|
2.2 Score on scale
Standard Deviation 0.91
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q1 at Day 29
|
2.7 Score on scale
Standard Deviation 1.11
|
3.0 Score on scale
Standard Deviation 0.93
|
2.8 Score on scale
Standard Deviation 1.18
|
2.2 Score on scale
Standard Deviation 1.08
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q2 at Day 8
|
2.7 Score on scale
Standard Deviation 0.95
|
2.9 Score on scale
Standard Deviation 0.83
|
2.8 Score on scale
Standard Deviation 0.94
|
2.1 Score on scale
Standard Deviation 0.95
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q2 at Day 29
|
3.1 Score on scale
Standard Deviation 1.06
|
3.2 Score on scale
Standard Deviation 0.96
|
2.9 Score on scale
Standard Deviation 1.18
|
2.3 Score on scale
Standard Deviation 1.20
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q3 at Day 8
|
2.5 Score on scale
Standard Deviation 0.94
|
2.8 Score on scale
Standard Deviation 0.90
|
2.6 Score on scale
Standard Deviation 0.99
|
1.9 Score on scale
Standard Deviation 1.02
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q3 at Day 29
|
2.7 Score on scale
Standard Deviation 1.09
|
3.0 Score on scale
Standard Deviation 1.08
|
2.6 Score on scale
Standard Deviation 1.18
|
2.1 Score on scale
Standard Deviation 1.12
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q4 at Day 8
|
2.6 Score on scale
Standard Deviation 0.97
|
2.7 Score on scale
Standard Deviation 0.89
|
2.6 Score on scale
Standard Deviation 0.98
|
1.9 Score on scale
Standard Deviation 0.90
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q4 at Day 29
|
2.8 Score on scale
Standard Deviation 1.15
|
3.1 Score on scale
Standard Deviation 1.07
|
2.8 Score on scale
Standard Deviation 1.07
|
2.2 Score on scale
Standard Deviation 1.08
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q5 at Day 8
|
2.6 Score on scale
Standard Deviation 0.98
|
2.8 Score on scale
Standard Deviation 0.93
|
2.5 Score on scale
Standard Deviation 1.00
|
1.9 Score on scale
Standard Deviation 0.91
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q5 at Day 29
|
2.8 Score on scale
Standard Deviation 1.11
|
3.0 Score on scale
Standard Deviation 1.06
|
2.8 Score on scale
Standard Deviation 1.11
|
2.0 Score on scale
Standard Deviation 1.06
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q6 at Day 8
|
2.6 Score on scale
Standard Deviation 1.00
|
2.8 Score on scale
Standard Deviation 0.94
|
2.5 Score on scale
Standard Deviation 0.92
|
1.9 Score on scale
Standard Deviation 1.00
|
|
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Q6 at Day 29
|
2.8 Score on scale
Standard Deviation 1.15
|
3.0 Score on scale
Standard Deviation 1.08
|
2.8 Score on scale
Standard Deviation 1.12
|
2.1 Score on scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: At Day 1 and 29Population: 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.
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.
Outcome measures
| Measure |
OralBalance Moisturizing Gel
n=101 Participants
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
n=98 Participants
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
n=98 Participants
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
n=99 Participants
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
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)
Q1, AUC At Day 1
|
2.6 Scores on scale/seconds
Standard Deviation 0.88
|
2.5 Scores on scale/seconds
Standard Deviation 0.79
|
2.5 Scores on scale/seconds
Standard Deviation 0.85
|
1.9 Scores on scale/seconds
Standard Deviation 0.79
|
|
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)
Q1, AUC At Day 29
|
2.7 Scores on scale/seconds
Standard Deviation 0.96
|
2.9 Scores on scale/seconds
Standard Deviation 0.88
|
2.7 Scores on scale/seconds
Standard Deviation 0.93
|
2.0 Scores on scale/seconds
Standard Deviation 0.89
|
|
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)
Q2, AUC At Day 1
|
2.7 Scores on scale/seconds
Standard Deviation 0.88
|
2.6 Scores on scale/seconds
Standard Deviation 0.80
|
2.6 Scores on scale/seconds
Standard Deviation 0.83
|
2.0 Scores on scale/seconds
Standard Deviation 0.87
|
|
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)
Q2, AUC At Day 29
|
2.8 Scores on scale/seconds
Standard Deviation 0.93
|
3.0 Scores on scale/seconds
Standard Deviation 0.85
|
2.8 Scores on scale/seconds
Standard Deviation 0.92
|
2.2 Scores on scale/seconds
Standard Deviation 0.95
|
|
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)
Q3, AUC At Day 1
|
2.6 Scores on scale/seconds
Standard Deviation 0.93
|
2.5 Scores on scale/seconds
Standard Deviation 0.75
|
2.5 Scores on scale/seconds
Standard Deviation 0.86
|
1.9 Scores on scale/seconds
Standard Deviation 0.85
|
|
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)
Q3, AUC At Day 29
|
2.7 Scores on scale/seconds
Standard Deviation 0.97
|
2.9 Scores on scale/seconds
Standard Deviation 0.86
|
2.7 Scores on scale/seconds
Standard Deviation 0.94
|
2.1 Scores on scale/seconds
Standard Deviation 0.96
|
|
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)
Q4, AUC At Day 1
|
3.1 Scores on scale/seconds
Standard Deviation 0.78
|
3.0 Scores on scale/seconds
Standard Deviation 0.73
|
2.9 Scores on scale/seconds
Standard Deviation 0.78
|
2.5 Scores on scale/seconds
Standard Deviation 0.95
|
|
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)
Q4, AUC At Day 29
|
3.1 Scores on scale/seconds
Standard Deviation 0.85
|
3.2 Scores on scale/seconds
Standard Deviation 0.79
|
3.0 Scores on scale/seconds
Standard Deviation 0.88
|
2.5 Scores on scale/seconds
Standard Deviation 0.95
|
|
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)
Q5, AUC At Day 1
|
2.6 Scores on scale/seconds
Standard Deviation 0.94
|
2.5 Scores on scale/seconds
Standard Deviation 0.79
|
2.5 Scores on scale/seconds
Standard Deviation 0.93
|
1.9 Scores on scale/seconds
Standard Deviation 0.91
|
|
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)
Q5, AUC At Day 29
|
2.7 Scores on scale/seconds
Standard Deviation 0.99
|
2.9 Scores on scale/seconds
Standard Deviation 0.86
|
2.7 Scores on scale/seconds
Standard Deviation 0.98
|
2.1 Scores on scale/seconds
Standard Deviation 0.95
|
|
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)
Q6, AUC At Day 1
|
2.6 Scores on scale/seconds
Standard Deviation 0.90
|
2.4 Scores on scale/seconds
Standard Deviation 0.80
|
2.5 Scores on scale/seconds
Standard Deviation 0.93
|
1.8 Scores on scale/seconds
Standard Deviation 0.88
|
|
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)
Q6, AUC At Day 29
|
2.8 Scores on scale/seconds
Standard Deviation 1.01
|
2.9 Scores on scale/seconds
Standard Deviation 0.86
|
2.7 Scores on scale/seconds
Standard Deviation 0.98
|
2.1 Scores on scale/seconds
Standard Deviation 0.93
|
|
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)
Q7, AUC At Day 1
|
2.4 Scores on scale/seconds
Standard Deviation 0.94
|
2.5 Scores on scale/seconds
Standard Deviation 0.75
|
2.5 Scores on scale/seconds
Standard Deviation 0.93
|
1.6 Scores on scale/seconds
Standard Deviation 0.93
|
|
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)
Q7, AUC At Day 29
|
2.6 Scores on scale/seconds
Standard Deviation 1.10
|
2.8 Scores on scale/seconds
Standard Deviation 0.92
|
2.5 Scores on scale/seconds
Standard Deviation 1.03
|
1.8 Scores on scale/seconds
Standard Deviation 0.94
|
|
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)
Q8, AUC At Day 1
|
2.5 Scores on scale/seconds
Standard Deviation 0.94
|
2.4 Scores on scale/seconds
Standard Deviation 0.80
|
2.4 Scores on scale/seconds
Standard Deviation 0.87
|
1.8 Scores on scale/seconds
Standard Deviation 0.86
|
|
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)
Q8, AUC At Day 29
|
2.7 Scores on scale/seconds
Standard Deviation 0.98
|
2.9 Scores on scale/seconds
Standard Deviation 0.89
|
2.6 Scores on scale/seconds
Standard Deviation 0.98
|
2.0 Scores on scale/seconds
Standard Deviation 0.94
|
|
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)
Q9, AUC At Day 1
|
2.6 Scores on scale/seconds
Standard Deviation 0.88
|
2.6 Scores on scale/seconds
Standard Deviation 0.75
|
2.5 Scores on scale/seconds
Standard Deviation 0.86
|
1.9 Scores on scale/seconds
Standard Deviation 0.84
|
|
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)
Q9, AUC At Day 29
|
2.7 Scores on scale/seconds
Standard Deviation 1.00
|
2.9 Scores on scale/seconds
Standard Deviation 0.84
|
2.7 Scores on scale/seconds
Standard Deviation 0.96
|
2.1 Scores on scale/seconds
Standard Deviation 0.93
|
|
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)
Q10, AUC At Day 1
|
2.8 Scores on scale/seconds
Standard Deviation 0.82
|
2.7 Scores on scale/seconds
Standard Deviation 0.69
|
2.7 Scores on scale/seconds
Standard Deviation 0.85
|
2.2 Scores on scale/seconds
Standard Deviation 0.95
|
|
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)
Q10, AUC At Day 29
|
2.9 Scores on scale/seconds
Standard Deviation 0.96
|
3.1 Scores on scale/seconds
Standard Deviation 0.77
|
2.9 Scores on scale/seconds
Standard Deviation 0.91
|
2.3 Scores on scale/seconds
Standard Deviation 0.93
|
|
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)
Q11, AUC At Day 1
|
2.6 Scores on scale/seconds
Standard Deviation 0.89
|
2.6 Scores on scale/seconds
Standard Deviation 0.81
|
2.5 Scores on scale/seconds
Standard Deviation 0.89
|
2.0 Scores on scale/seconds
Standard Deviation 0.89
|
|
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)
Q11, AUC At Day 29
|
2.8 Scores on scale/seconds
Standard Deviation 0.92
|
2.9 Scores on scale/seconds
Standard Deviation 0.85
|
2.8 Scores on scale/seconds
Standard Deviation 0.95
|
2.2 Scores on scale/seconds
Standard Deviation 0.92
|
|
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)
Q12, AUC At Day 1
|
2.2 Scores on scale/seconds
Standard Deviation 0.96
|
2.3 Scores on scale/seconds
Standard Deviation 0.79
|
2.2 Scores on scale/seconds
Standard Deviation 0.87
|
1.8 Scores on scale/seconds
Standard Deviation 0.96
|
|
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)
Q12, AUC At Day 29
|
2.4 Scores on scale/seconds
Standard Deviation 1.06
|
2.6 Scores on scale/seconds
Standard Deviation 0.90
|
2.4 Scores on scale/seconds
Standard Deviation 1.01
|
1.8 Scores on scale/seconds
Standard Deviation 0.86
|
Adverse Events
OralBalance Moisturizing Gel
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Oral Rinse
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Moisturizing Mouth Spray
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Water Only Use
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OralBalance Moisturizing Gel
n=101 participants at risk
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
n=98 participants at risk
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
n=98 participants at risk
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
n=99 participants at risk
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
Other adverse events
| Measure |
OralBalance Moisturizing Gel
n=101 participants at risk
All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.
|
Oral Rinse
n=98 participants at risk
All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.
|
Moisturizing Mouth Spray
n=98 participants at risk
All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.
|
Water Only Use
n=99 participants at risk
All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Injury, poisoning and procedural complications
TRAUMATIC ULCER
|
3.0%
3/101 • Approximately 29 days
|
3.1%
3/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
2.0%
2/99 • Approximately 29 days
|
|
Injury, poisoning and procedural complications
Tongue Injury
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Injury, poisoning and procedural complications
MOUTH INJURY
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Injury, poisoning and procedural complications
LIP INJURY
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Respiratory, thoracic and mediastinal disorders
THROAT TIGHTNESS
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGAL PAIN
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Infections and infestations
ORAL HERPES
|
2.0%
2/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
3.0%
3/99 • Approximately 29 days
|
|
Infections and infestations
BRONCHITIS
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/101 • Approximately 29 days
|
3.1%
3/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Infections and infestations
HORDEOLUM
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
General disorders
DEVICE EXPULSION
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
General disorders
APPLICATION SITE ANAESTHESIA
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
General disorders
PAIN
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
General disorders
PRODUCT TASTE ABNORMAL
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
General disorders
APPLICATION SITE PAIN
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
General disorders
DEVICE FAILURE
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
2.0%
2/99 • Approximately 29 days
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Gastrointestinal disorders
LIP DRY
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Gastrointestinal disorders
CHEILITIS
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Gastrointestinal disorders
NAUSEA
|
0.99%
1/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Gastrointestinal disorders
LIP EXFOLIATION
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Gastrointestinal disorders
GINGIVAL INFLAMMATION
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Gastrointestinal disorders
TONGUE COATED
|
0.99%
1/101 • Approximately 29 days
|
3.1%
3/98 • Approximately 29 days
|
2.0%
2/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Gastrointestinal disorders
HYPOAESTHESIA ORAL
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Gastrointestinal disorders
TONGUE DISORDER
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Gastrointestinal disorders
ORAL MUCOSAL EXFOLIATION
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Gastrointestinal disorders
LIP ULCERATION
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/101 • Approximately 29 days
|
1.0%
1/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/99 • Approximately 29 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/101 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
0.00%
0/98 • Approximately 29 days
|
1.0%
1/99 • Approximately 29 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER