A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT03494985
Collaborator
(none)
422
4
3.8
Study Details
Study Description
Brief Summary
This study assessed the efficacy of three dry mouth products (including an experimental Oralbalance gel, oral rinse, and moisturizing spray) to relieve the feeling of dry mouth compared to water, in dry mouth population over a period of 28 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This was a multi-centered (two-sites), examiner-blinded, four treatment arms, stratified (by Modified Dry Mouth Inventory [DMI] score), randomized, parallel group study in participants with self-reported dry mouth symptoms as determined by participant responses to the DMI. Participants used their assigned dry mouth treatment at home for 28 days.
Study Design
Study Type:
Interventional
Actual Enrollment
:
422 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The examiner and site staff reviewing the efficacy assessments were blinded to the treatment allocation of participants. All other study personnel (study statistician, data management staff and other employees of the Sponsor who may influence study outcomes) were blinded to the study treatments.
Primary Purpose:
Treatment
Official Title:
A Clinical Study to Evaluate the Efficacy of an Experimental Oralbalance Gel, Oral Rinse and Spray Versus Water
Actual Study Start Date
:
Sep 17, 2013
Actual Primary Completion Date
:
Jan 10, 2014
Actual Study Completion Date
:
Jan 10, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: Experimental Oralbalance Moisturizing Gel
Participants placed approximately a half inch length of the gel onto the tongue and spread thoroughly using their tongue. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.
|
| Experimental: Oral rinse All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits. |
Device: Biotene Original Oral Rinse
Participants rinsed their mouth with 15 milliliters (mL) of oral rinse for 30 seconds and spat out. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.
|
| Experimental: 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. |
Device: Biotene Moisturizing Mouth Spray
Participants sprayed one jet directly into their mouth. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.
|
| Sham Comparator: Water only use All the participants in this arm used water as instructed under the supervision of trained site staff on their visits. |
Other: Water
Participants were allowed to take only one measured sip of water (15 mL) 30 minutes before the supervised product use. After the supervised treatment at the site, participants assigned to the water only treatment were allowed to sip water as often as required.
|
Outcome Measures
Primary Outcome Measures
- Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth) [At Day 29 of treatment (2 hours after supervised product use)]
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.
Secondary Outcome Measures
- Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29 [At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use)]
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.
- Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1 [At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use)]
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.
- Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I) [At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use)]
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.
- Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8 [At Day 8 (2 hours after supervised product use)]
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.
- Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II) [At Day 8 and 29]
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.
- 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) [At Day 1 and 29]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
35 Years
to 84 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
-
Understands and is willing, able and likely to comply with all study procedures and restrictions.
-
Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination., b) Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements. Subjects with stable and controlled medical conditions with no overt medical conditions which would contraindicate participation (in the opinion of the Investigator or medically qualified designee) which would interfere with the conduct of the study.
-
Self reported feeling of a dry mouth according to the modified DMI questions. Subject must answer at least 3 out of 5 questions with 'agree a little', 'agree' or 'strongly agree'.
Exclusion Criteria:
-
Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
-
Women who are breast-feeding.
-
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
-
Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
-
Previous participation in this study.
-
Recent history (within the last 1 year) of alcohol or other substance abuse.
-
An employee of the sponsor or the study site or members of their immediate family.
-
Subject works in one of the following: Advertising, Journalism, Public Relations, Manufacturing, retail or distribution of medicines, medical devices or healthcare products, Market Research or Marketing.
-
Use of prescription systemic parasympathetic medications (e.g. Pilocarpine), for the treatment of the feeling of dry mouth.
-
At the discretion of the examiner, subjects currently under the care of a dental/medical professional specifically for the treatment of dry mouth.
-
Evidence of gross intra-oral neglect or need for extensive dental therapy.
-
Denture wearer (partial or complete dentures).
-
Subject with dental implants.
-
Subjects with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration).
-
Subject is currently undergoing radiotherapy and/or chemotherapy treatment.
-
Any condition the investigator identifies that can confound the subject's ability to properly participate in the study e.g. Alzheimer's Disease.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT03494985
Other Study ID Numbers:
- 202902
- RH01986
First Posted:
Apr 11, 2018
Last Update Posted:
Sep 26, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from 2 sites in United States of America. |
|---|---|
| Pre-assignment Detail | 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 |
|---|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | OralBalance Moisturizing Gel | Oral Rinse | Moisturizing Mouth Spray | Water Only Use | Total |
|---|---|---|---|---|---|
| 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 Participants | 101 | 98 | 98 | 99 | 396 |
| Age (Years) [Geometric Mean (Standard Deviation) ] | |||||
| Geometric Mean (Standard Deviation) [Years] |
56.2
(10.19)
|
52.6
(10.87)
|
54.0
(9.80)
|
52.7
(9.61)
|
53.9
(10.20)
|
| Sex: Female, Male (Count of 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) (Count of 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%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
2
2%
|
0
0%
|
0
0%
|
2
0.5%
|
| Asian |
2
2%
|
1
1%
|
2
2%
|
2
2%
|
7
1.8%
|
| Native Hawaiian or Other Pacific Islander |
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%
|
1
1%
|
0
0%
|
0
0%
|
2
0.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 95 | 92 | 91 | 92 |
| Mean (Standard Deviation) [Score on scale] |
2.7
(1.07)
|
2.9
(0.99)
|
2.6
(1.02)
|
2.0
(0.95)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | OralBalance Moisturizing Gel, Water Only Use |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| 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 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | First named treatment minus second named treatment such that a positive value favours the first named treatment. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Oral Rinse, Water Only Use |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| 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 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | First named treatment minus second named treatment such that a positive value favours the first named treatment. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Moisturizing Mouth Spray, Water Only Use |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| 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 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | First named treatment minus second named treatment such that a positive value favours the first named treatment. | |
| Title | Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29 |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 101 | 98 | 98 | 99 |
| At 30 mins |
3.0
(0.94)
|
3.2
(0.86)
|
3.1
(1.00)
|
2.3
(0.97)
|
| At 1 hour |
2.9
(0.97)
|
3.2
(0.82)
|
2.9
(0.97)
|
2.2
(0.95)
|
| At 4 hours |
2.5
(1.11)
|
2.7
(1.03)
|
2.5
(1.02)
|
1.9
(0.95)
|
| Title | Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1 |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 101 | 98 | 98 | 99 |
| At 30 minutes |
2.8
(0.97)
|
2.8
(0.81)
|
2.7
(0.97)
|
2.2
(0.97)
|
| At 1 hour |
2.8
(0.89)
|
2.7
(0.81)
|
2.7
(0.95)
|
2.0
(0.94)
|
| At 2 hours |
2.6
(0.97)
|
2.4
(0.89)
|
2.5
(0.97)
|
1.8
(0.86)
|
| At 4 hours |
2.4
(1.09)
|
2.3
(1.06)
|
2.3
(1.02)
|
1.6
(0.88)
|
| Title | Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 101 | 98 | 98 | 99 |
| Q2 at Day 1, 30 minutes |
3.1
(0.92)
|
3.0
(0.79)
|
2.9
(1.00)
|
2.5
(1.10)
|
| Q2 at Day 1, 1 hour |
2.9
(0.93)
|
2.8
(0.82)
|
2.8
(1.00)
|
2.2
(1.03)
|
| Q2 at Day 1, 2 hours |
2.7
(0.97)
|
2.5
(0.93)
|
2.6
(0.99)
|
2.0
(0.95)
|
| Q2 at Day 1, 4 hours |
2.4
(1.09)
|
2.4
(1.05)
|
2.4
(1.03)
|
1.8
(0.94)
|
| Q2 at Day 29, 30 minutes |
3.0
(1.00)
|
3.3
(0.85)
|
3.2
(1.07)
|
2.4
(0.97)
|
| Q2 at Day 29, 1 hour |
3.0
(0.87)
|
3.2
(0.85)
|
3.0
(1.00)
|
2.3
(1.03)
|
| Q2 at Day 29. 2 hours |
2.7
(1.04)
|
3.0
(0.93)
|
2.8
(0.99)
|
2.2
(1.01)
|
| Q2 at Day 29, 4 hours |
2.7
(1.06)
|
2.8
(1.00)
|
2.6
(1.07)
|
2.0
(0.99)
|
| Q3 at Day 1, 30 minutes |
3.1
(0.97)
|
3.0
(0.82)
|
2.8
(1.02)
|
2.3
(1.05)
|
| Q3 at Day 1, 1 hour |
2.8
(1.01)
|
2.7
(0.78)
|
2.7
(0.93)
|
2.1
(1.07)
|
| Q3 at Day 1, 2 hours |
2.6
(1.00)
|
2.4
(0.91)
|
2.5
(0.98)
|
1.9
(0.93)
|
| Q3 at Day 1, 4 hours |
2.3
(1.11)
|
2.2
(1.00)
|
2.3
(1.05)
|
1.6
(0.86)
|
| Q3 at Day 29, 30 minutes |
3.0
(0.98)
|
3.3
(0.87)
|
3.1
(1.02)
|
2.3
(0.99)
|
| Q3 at Day 29, 1 hour |
2.8
(1.01)
|
3.2
(0.86)
|
3.0
(1.04)
|
2.2
(1.01)
|
| Q3 at Day 29. 2 hours |
2.7
(1.08)
|
2.9
(0.97)
|
2.7
(1.06)
|
2.0
(1.02)
|
| Q3 at Day 29, 4 hours |
2.6
(1.04)
|
2.6
(1.01)
|
2.5
(1.08)
|
2.0
(1.05)
|
| Q4 at Day 1, 30 minutes |
3.6
(0.88)
|
3.4
(0.83)
|
3.4
(0.94)
|
3.0
(1.12)
|
| Q4 at Day 1, 1 hour |
3.3
(0.95)
|
3.2
(0.75)
|
3.1
(0.95)
|
2.6
(1.05)
|
| Q4 at Day 1, 2 hours |
3.1
(0.93)
|
2.9
(0.83)
|
2.9
(0.88)
|
2.4
(1.00)
|
| Q4 at Day 1, 4 hours |
2.9
(0.91)
|
2.8
(0.92)
|
2.8
(1.00)
|
2.3
(0.99)
|
| Q4 at Day 29, 30 minutes |
3.3
(0.81)
|
3.5
(0.84)
|
3.4
(0.97)
|
2.7
(1.02)
|
| Q4 at Day 29, 1 hour |
3.2
(0.87)
|
3.4
(0.78)
|
3.2
(0.95)
|
2.6
(0.99)
|
| Q4 at Day 29. 2 hours |
3.1
(0.91)
|
3.3
(0.87)
|
3.0
(1.02)
|
2.5
(0.97)
|
| Q4 at Day 29, 4 hours |
3.0
(1.02)
|
3.0
(0.90)
|
2.7
(1.01)
|
2.3
(1.04)
|
| Q5 at Day 1, 30 minutes |
3.1
(1.08)
|
3.0
(0.92)
|
3.0
(1.13)
|
2.5
(1.13)
|
| Q5 at Day 1, 1 hour |
2.8
(1.00)
|
2.8
(0.83)
|
2.9
(1.08)
|
2.1
(1.11)
|
| Q5 at Day 1, 2 hours |
2.6
(1.07)
|
2.4
(0.93)
|
2.5
(1.02)
|
1.9
(1.06)
|
| Q5 at Day 1, 4 hours |
2.3
(1.10)
|
2.2
(1.04)
|
2.2
(1.10)
|
1.6
(0.91)
|
| Q5 at Day 29, 30 minutes |
3.1
(0.95)
|
3.3
(0.93)
|
3.1
(1.03)
|
2.4
(1.00)
|
| Q5 at Day 29, 1 hour |
2.9
(1.09)
|
3.1
(0.92)
|
2.9
(1.04)
|
2.2
(1.06)
|
| Q5 at Day 29. 2 hours |
2.7
(1.06)
|
2.9
(0.94)
|
2.7
(1.10)
|
2.1
(1.00)
|
| Q5 at Day 29, 4 hours |
2.6
(1.10)
|
2.6
(0.98)
|
2.4
(1.09)
|
2.0
(1.00)
|
| Q6 at Day 1, 30 minutes |
3.1
(1.06)
|
3.0
(0.86)
|
2.9
(1.12)
|
2.4
(1.18)
|
| Q6 at Day 1, 1 hour |
2.8
(1.06)
|
2.7
(0.89)
|
2.8
(1.09)
|
2.0
(1.06)
|
| Q6 at Day 1, 2 hours |
2.6
(1.02)
|
2.4
(0.94)
|
2.4
(1.05)
|
1.8
(0.98)
|
| Q6 at Day 1, 4 hours |
2.2
(1.08)
|
2.2
(1.05)
|
2.1
(1.07)
|
1.6
(0.86)
|
| Q6 at Day 29, 30 minutes |
3.1
(1.01)
|
3.3
(0.92)
|
3.1
(1.07)
|
2.3
(1.04)
|
| Q6 at Day 29, 1 hour |
2.9
(1.09)
|
3.0
(0.94)
|
3.0
(1.04)
|
2.2
(1.04)
|
| Q6 at Day 29. 2 hours |
2.7
(1.08)
|
2.9
(0.94)
|
2.7
(1.10)
|
2.0
(0.99)
|
| Q6 at Day 29, 4 hours |
2.6
(1.14)
|
2.5
(0.97)
|
2.4
(1.09)
|
2.0
(0.98)
|
| Q7 at Day 1, 30 minutes |
2.8
(1.02)
|
3.3
(0.92)
|
3.2
(1.10)
|
1.8
(1.06)
|
| Q7 at Day 1, 1 hour |
2.5
(0.99)
|
2.9
(0.80)
|
2.7
(1.02)
|
1.7
(1.06)
|
| Q7 at Day 1, 2 hours |
2.4
(1.12)
|
2.4
(0.85)
|
2.4
(1.04)
|
1.6
(0.91)
|
| Q7 at Day 1, 4 hours |
2.1
(1.02)
|
2.2
(0.98)
|
2.1
(1.06)
|
1.5
(0.89)
|
| Q7 at Day 29, 30 minutes |
2.8
(1.12)
|
3.2
(0.84)
|
3.0
(1.16)
|
2.0
(1.04)
|
| Q7 at Day 29, 1 hour |
2.7
(1.19)
|
3.0
(0.89)
|
2.7
(1.08)
|
1.9
(1.03)
|
| Q7 at Day 29. 2 hours |
2.5
(1.18)
|
2.7
(1.03)
|
2.4
(1.13)
|
1.8
(0.98)
|
| Q7 at Day 29. 4 hours |
2.4
(1.20)
|
2.5
(1.11)
|
2.2
(1.12)
|
1.7
(0.91)
|
| Q8 at Day 1, 30 minutes |
2.8
(0.99)
|
3.0
(0.92)
|
2.9
(1.18)
|
2.2
(1.12)
|
| Q8 at Day 1, 1 hour |
2.8
(1.00)
|
2.7
(0.88)
|
2.6
(1.01)
|
2.0
(1.08)
|
| Q8 at Day 1, 2 hours |
2.5
(1.13)
|
2.3
(0.93)
|
2.4
(0.97)
|
1.7
(0.90)
|
| Q8 at Day 1, 4 hours |
2.2
(1.07)
|
2.2
(1.06)
|
2.2
(1.04)
|
1.6
(0.94)
|
| Q8 at Day 29, 30 minutes |
3.0
(1.00)
|
3.3
(0.95)
|
3.0
(1.09)
|
2.2
(0.98)
|
| Q8 at Day 29, 1 hour |
2.9
(1.05)
|
3.1
(0.94)
|
2.8
(1.11)
|
2.1
(1.03)
|
| Q8 at Day 29. 2 hours |
2.6
(1.04)
|
2.9
(0.99)
|
2.6
(1.06)
|
2.0
(0.97)
|
| Q8 at Day 29. 4 hours |
2.5
(1.09)
|
2.6
(1.02)
|
2.3
(1.13)
|
2.0
(1.02)
|
| Q9 at Day 1, 30 minutes |
3.0
(0.96)
|
3.1
(0.84)
|
2.9
(1.13)
|
2.3
(1.10)
|
| Q9 at Day 1, 1 hour |
2.8
(0.92)
|
2.8
(0.80)
|
2.7
(1.01)
|
2.1
(1.04)
|
| Q9 at Day 1, 2 hours |
2.6
(1.01)
|
2.5
(0.87)
|
2.5
(1.00)
|
1.9
(0.95)
|
| Q9 at Day 1, 4 hours |
2.4
(1.11)
|
2.3
(1.04)
|
2.2
(0.98)
|
1.7
(0.85)
|
| Q9 at Day 29, 30 minutes |
3.0
(1.05)
|
3.3
(0.90)
|
3.1
(1.03)
|
2.3
(1.03)
|
| Q9 at Day 29, 1 hour |
2.9
(1.03)
|
3.1
(0.90)
|
3.0
(1.02)
|
2.3
(1.01)
|
| Q9 at Day 29. 2 hours |
2.6
(1.07)
|
2.9
(0.93)
|
2.7
(1.07)
|
2.0
(0.98)
|
| Q9 at Day 29. 4 hours |
2.6
(1.11)
|
2.7
(0.96)
|
2.4
(1.07)
|
2.0
(1.01)
|
| Q10 at Day 1, 30 minutes |
3.1
(0.95)
|
3.2
(0.85)
|
3.1
(1.07)
|
2.6
(1.18)
|
| Q10 at Day 1, 1 hour |
2.9
(0.92)
|
3.0
(0.74)
|
3.0
(0.96)
|
2.3
(1.03)
|
| Q10 at Day 1, 2 hours |
2.8
(1.05)
|
2.7
(0.86)
|
2.7
(0.93)
|
2.2
(1.00)
|
| Q10 at Day 1, 4 hours |
2.8
(0.99)
|
2.6
(1.05)
|
2.5
(1.08)
|
2.1
(1.05)
|
| Q10 at Day 29, 30 minutes |
3.2
(0.92)
|
3.5
(0.81)
|
3.2
(1.02)
|
2.4
(0.99)
|
| Q10 at Day 29, 1 hour |
3.0
(1.01)
|
3.3
(0.79)
|
3.0
(0.99)
|
2.4
(0.94)
|
| Q10 at Day 29. 2 hours |
2.9
(1.05)
|
3.1
(0.83)
|
2.8
(1.02)
|
2.3
(0.95)
|
| Q10 at Day 29. 4 hours |
2.8
(1.08)
|
2.9
(0.92)
|
2.7
(1.03)
|
2.2
(1.02)
|
| Q11 at Day 1, 30 minutes |
3.0
(0.91)
|
3.1
(0.94)
|
3.1
(1.08)
|
2.4
(1.18)
|
| Q11 at Day 1, 1 hour |
2.8
(0.91)
|
2.9
(0.89)
|
2.8
(1.06)
|
2.2
(1.01)
|
| Q11 at Day 1, 2 hours |
2.6
(1.01)
|
2.6
(0.92)
|
2.4
(0.98)
|
2.0
(1.02)
|
| Q11 at Day 1, 4 hours |
2.5
(1.09)
|
2.4
(1.05)
|
2.3
(1.05)
|
1.9
(0.96)
|
| Q11 at Day 29, 30 minutes |
3.1
(0.97)
|
3.3
(0.94)
|
3.2
(0.99)
|
2.4
(1.03)
|
| Q11 at Day 29, 1 hour |
2.9
(0.92)
|
3.1
(0.90)
|
3.0
(0.98)
|
2.3
(1.01)
|
| Q11 at Day 29, 2 hours |
2.7
(0.99)
|
2.9
(0.94)
|
2.7
(1.06)
|
2.1
(0.96)
|
| Q11 at Day 29. 4 hours |
2.6
(1.05)
|
2.7
(0.94)
|
2.5
(1.09)
|
2.1
(0.97)
|
| Q12 at Day 1, 30 minutes |
2.6
(1.16)
|
3.1
(1.01)
|
2.9
(1.21)
|
2.2
(1.25)
|
| Q12 at Day 1, 1 hour |
2.3
(1.12)
|
2.7
(1.01)
|
2.5
(1.03)
|
2.0
(1.26)
|
| Q12 at Day 1, 2 hours |
2.2
(1.07)
|
2.1
(0.91)
|
2.1
(0.99)
|
1.7
(0.94)
|
| Q12 at Day 1, 4 hours |
1.9
(0.96)
|
2.0
(0.97)
|
2.0
(0.92)
|
1.6
(0.93)
|
| Q12 at Day 29, 30 minutes |
2.8
(1.12)
|
3.1
(0.96)
|
2.9
(1.10)
|
2.1
(0.98)
|
| Q12 at Day 29, 1 hour |
2.5
(1.11)
|
2.8
(0.97)
|
2.6
(1.11)
|
2.0
(0.95)
|
| Q12 at Day 29. 2 hours |
2.3
(1.12)
|
2.6
(0.99)
|
2.3
(1.15)
|
1.7
(0.87)
|
| Q12 at Day 29. 4 hours |
2.3
(1.18)
|
2.3
(1.06)
|
2.1
(1.07)
|
1.7
(0.91)
|
| Title | Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8 |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 101 | 98 | 98 | 99 |
| Q1 at Day 8, 2 hours |
2.8
(0.98)
|
3.0
(0.86)
|
2.9
(0.86)
|
2.1
(0.92)
|
| Q2 at Day 8, 2 hours |
2.9
(0.97)
|
3.0
(0.79)
|
3.0
(1.00)
|
2.2
(0.98)
|
| Q3 at Day 8, 2 hours |
2.8
(1.04)
|
2.9
(0.76)
|
2.8
(0.97)
|
2.0
(0.92)
|
| Q4 at Day 8, 2 hours |
3.3
(0.89)
|
3.2
(0.75)
|
3.2
(0.97)
|
2.5
(1.00)
|
| Q5 at Day 8, 2 hours |
2.8
(1.00)
|
3.0
(0.93)
|
2.9
(1.07)
|
2.1
(1.04)
|
| Q6 at Day 8, 2 hours |
2.8
(0.98)
|
2.9
(0.90)
|
2.8
(1.11)
|
2.0
(1.09)
|
| Q7 at Day 8, 2 hours |
2.6
(1.09)
|
2.9
(0.84)
|
2.6
(1.02)
|
1.5
(0.84)
|
| Q8 at Day 8, 2 hours |
2.7
(1.00)
|
2.9
(0.90)
|
2.7
(1.07)
|
1.9
(0.94)
|
| Q9 at Day 8, 2 hours |
2.8
(0.97)
|
2.9
(0.81)
|
2.8
(1.07)
|
2.1
(0.98)
|
| Q10 at Day 8, 2 hours |
3.0
(0.92)
|
3.2
(0.77)
|
3.0
(0.99)
|
2.4
(1.01)
|
| Q11 at Day 8, 2 hours |
2.9
(0.90)
|
3.0
(0.81)
|
2.8
(1.02)
|
2.1
(1.02)
|
| Q12 at Day 8, 2 hours |
2.3
(1.10)
|
2.7
(0.84)
|
2.4
(1.03)
|
1.7
(0.91)
|
| Title | Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 101 | 98 | 98 | 99 |
| Q1 at Day 8 |
2.5
(0.96)
|
2.7
(0.93)
|
2.6
(1.00)
|
2.2
(0.91)
|
| Q1 at Day 29 |
2.7
(1.11)
|
3.0
(0.93)
|
2.8
(1.18)
|
2.2
(1.08)
|
| Q2 at Day 8 |
2.7
(0.95)
|
2.9
(0.83)
|
2.8
(0.94)
|
2.1
(0.95)
|
| Q2 at Day 29 |
3.1
(1.06)
|
3.2
(0.96)
|
2.9
(1.18)
|
2.3
(1.20)
|
| Q3 at Day 8 |
2.5
(0.94)
|
2.8
(0.90)
|
2.6
(0.99)
|
1.9
(1.02)
|
| Q3 at Day 29 |
2.7
(1.09)
|
3.0
(1.08)
|
2.6
(1.18)
|
2.1
(1.12)
|
| Q4 at Day 8 |
2.6
(0.97)
|
2.7
(0.89)
|
2.6
(0.98)
|
1.9
(0.90)
|
| Q4 at Day 29 |
2.8
(1.15)
|
3.1
(1.07)
|
2.8
(1.07)
|
2.2
(1.08)
|
| Q5 at Day 8 |
2.6
(0.98)
|
2.8
(0.93)
|
2.5
(1.00)
|
1.9
(0.91)
|
| Q5 at Day 29 |
2.8
(1.11)
|
3.0
(1.06)
|
2.8
(1.11)
|
2.0
(1.06)
|
| Q6 at Day 8 |
2.6
(1.00)
|
2.8
(0.94)
|
2.5
(0.92)
|
1.9
(1.00)
|
| Q6 at Day 29 |
2.8
(1.15)
|
3.0
(1.08)
|
2.8
(1.12)
|
2.1
(1.11)
|
| 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) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 101 | 98 | 98 | 99 |
| Q1, AUC At Day 1 |
2.6
(0.88)
|
2.5
(0.79)
|
2.5
(0.85)
|
1.9
(0.79)
|
| Q1, AUC At Day 29 |
2.7
(0.96)
|
2.9
(0.88)
|
2.7
(0.93)
|
2.0
(0.89)
|
| Q2, AUC At Day 1 |
2.7
(0.88)
|
2.6
(0.80)
|
2.6
(0.83)
|
2.0
(0.87)
|
| Q2, AUC At Day 29 |
2.8
(0.93)
|
3.0
(0.85)
|
2.8
(0.92)
|
2.2
(0.95)
|
| Q3, AUC At Day 1 |
2.6
(0.93)
|
2.5
(0.75)
|
2.5
(0.86)
|
1.9
(0.85)
|
| Q3, AUC At Day 29 |
2.7
(0.97)
|
2.9
(0.86)
|
2.7
(0.94)
|
2.1
(0.96)
|
| Q4, AUC At Day 1 |
3.1
(0.78)
|
3.0
(0.73)
|
2.9
(0.78)
|
2.5
(0.95)
|
| Q4, AUC At Day 29 |
3.1
(0.85)
|
3.2
(0.79)
|
3.0
(0.88)
|
2.5
(0.95)
|
| Q5, AUC At Day 1 |
2.6
(0.94)
|
2.5
(0.79)
|
2.5
(0.93)
|
1.9
(0.91)
|
| Q5, AUC At Day 29 |
2.7
(0.99)
|
2.9
(0.86)
|
2.7
(0.98)
|
2.1
(0.95)
|
| Q6, AUC At Day 1 |
2.6
(0.90)
|
2.4
(0.80)
|
2.5
(0.93)
|
1.8
(0.88)
|
| Q6, AUC At Day 29 |
2.8
(1.01)
|
2.9
(0.86)
|
2.7
(0.98)
|
2.1
(0.93)
|
| Q7, AUC At Day 1 |
2.4
(0.94)
|
2.5
(0.75)
|
2.5
(0.93)
|
1.6
(0.93)
|
| Q7, AUC At Day 29 |
2.6
(1.10)
|
2.8
(0.92)
|
2.5
(1.03)
|
1.8
(0.94)
|
| Q8, AUC At Day 1 |
2.5
(0.94)
|
2.4
(0.80)
|
2.4
(0.87)
|
1.8
(0.86)
|
| Q8, AUC At Day 29 |
2.7
(0.98)
|
2.9
(0.89)
|
2.6
(0.98)
|
2.0
(0.94)
|
| Q9, AUC At Day 1 |
2.6
(0.88)
|
2.6
(0.75)
|
2.5
(0.86)
|
1.9
(0.84)
|
| Q9, AUC At Day 29 |
2.7
(1.00)
|
2.9
(0.84)
|
2.7
(0.96)
|
2.1
(0.93)
|
| Q10, AUC At Day 1 |
2.8
(0.82)
|
2.7
(0.69)
|
2.7
(0.85)
|
2.2
(0.95)
|
| Q10, AUC At Day 29 |
2.9
(0.96)
|
3.1
(0.77)
|
2.9
(0.91)
|
2.3
(0.93)
|
| Q11, AUC At Day 1 |
2.6
(0.89)
|
2.6
(0.81)
|
2.5
(0.89)
|
2.0
(0.89)
|
| Q11, AUC At Day 29 |
2.8
(0.92)
|
2.9
(0.85)
|
2.8
(0.95)
|
2.2
(0.92)
|
| Q12, AUC At Day 1 |
2.2
(0.96)
|
2.3
(0.79)
|
2.2
(0.87)
|
1.8
(0.96)
|
| Q12, AUC At Day 29 |
2.4
(1.06)
|
2.6
(0.90)
|
2.4
(1.01)
|
1.8
(0.86)
|
Adverse Events
| Time Frame | Approximately 29 days | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | OralBalance Moisturizing Gel | Oral Rinse | Moisturizing Mouth Spray | Water Only Use | ||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 0/99 (0%) | ||||
Serious Adverse Events |
||||||||
| OralBalance Moisturizing Gel | Oral Rinse | Moisturizing Mouth Spray | Water Only Use | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/101 (0%) | 1/98 (1%) | 2/98 (2%) | 0/99 (0%) | ||||
| Cardiac disorders | ||||||||
| CARDIAC ARREST | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 0/99 (0%) | ||||
| Infections and infestations | ||||||||
| DIVERTICULITIS | 0/101 (0%) | 0/98 (0%) | 1/98 (1%) | 0/99 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| OVARIAN CANCER | 0/101 (0%) | 0/98 (0%) | 1/98 (1%) | 0/99 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| OralBalance Moisturizing Gel | Oral Rinse | Moisturizing Mouth Spray | Water Only Use | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/101 (16.8%) | 21/98 (21.4%) | 12/98 (12.2%) | 20/99 (20.2%) | ||||
| Gastrointestinal disorders | ||||||||
| PARAESTHESIA ORAL | 1/101 (1%) | 0/98 (0%) | 0/98 (0%) | 0/99 (0%) | ||||
| MOUTH HAEMORRHAGE | 1/101 (1%) | 0/98 (0%) | 0/98 (0%) | 0/99 (0%) | ||||
| LIP DRY | 1/101 (1%) | 0/98 (0%) | 0/98 (0%) | 0/99 (0%) | ||||
| CHEILITIS | 1/101 (1%) | 0/98 (0%) | 0/98 (0%) | 0/99 (0%) | ||||
| NAUSEA | 1/101 (1%) | 0/98 (0%) | 1/98 (1%) | 0/99 (0%) | ||||
| LIP EXFOLIATION | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 0/99 (0%) | ||||
| GINGIVAL PAIN | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 1/99 (1%) | ||||
| ABDOMINAL DISCOMFORT | 0/101 (0%) | 1/98 (1%) | 1/98 (1%) | 0/99 (0%) | ||||
| DRY MOUTH | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 0/99 (0%) | ||||
| GLOSSODYNIA | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 0/99 (0%) | ||||
| GINGIVAL INFLAMMATION | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 1/99 (1%) | ||||
| TONGUE COATED | 1/101 (1%) | 3/98 (3.1%) | 2/98 (2%) | 1/99 (1%) | ||||
| HYPOAESTHESIA ORAL | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 0/99 (0%) | ||||
| TONGUE DISORDER | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| ORAL MUCOSAL EXFOLIATION | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| GINGIVAL BLEEDING | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| LIP ULCERATION | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| TOOTHACHE | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| General disorders | ||||||||
| DEVICE EXPULSION | 1/101 (1%) | 0/98 (0%) | 0/98 (0%) | 0/99 (0%) | ||||
| APPLICATION SITE ANAESTHESIA | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 0/99 (0%) | ||||
| PAIN | 0/101 (0%) | 0/98 (0%) | 1/98 (1%) | 0/99 (0%) | ||||
| PRODUCT TASTE ABNORMAL | 0/101 (0%) | 0/98 (0%) | 1/98 (1%) | 0/99 (0%) | ||||
| APPLICATION SITE PAIN | 0/101 (0%) | 0/98 (0%) | 1/98 (1%) | 0/99 (0%) | ||||
| DEVICE FAILURE | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 2/99 (2%) | ||||
| Infections and infestations | ||||||||
| ORAL HERPES | 2/101 (2%) | 1/98 (1%) | 0/98 (0%) | 3/99 (3%) | ||||
| BRONCHITIS | 1/101 (1%) | 0/98 (0%) | 0/98 (0%) | 0/99 (0%) | ||||
| NASOPHARYNGITIS | 0/101 (0%) | 3/98 (3.1%) | 1/98 (1%) | 1/99 (1%) | ||||
| HORDEOLUM | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 0/99 (0%) | ||||
| TOOTH ABSCESS | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| LARYNGITIS | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| TRAUMATIC ULCER | 3/101 (3%) | 3/98 (3.1%) | 0/98 (0%) | 0/99 (0%) | ||||
| TOOTH FRACTURE | 1/101 (1%) | 0/98 (0%) | 0/98 (0%) | 2/99 (2%) | ||||
| Tongue Injury | 1/101 (1%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| CONTUSION | 0/101 (0%) | 0/98 (0%) | 1/98 (1%) | 0/99 (0%) | ||||
| FALL | 0/101 (0%) | 0/98 (0%) | 1/98 (1%) | 0/99 (0%) | ||||
| MOUTH INJURY | 0/101 (0%) | 0/98 (0%) | 1/98 (1%) | 1/99 (1%) | ||||
| THERMAL BURN | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| LIP INJURY | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| MUSCULOSKELETAL PAIN | 0/101 (0%) | 0/98 (0%) | 0/98 (0%) | 1/99 (1%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| BASAL CELL CARCINOMA | 1/101 (1%) | 0/98 (0%) | 0/98 (0%) | 0/99 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| THROAT TIGHTNESS | 1/101 (1%) | 0/98 (0%) | 0/98 (0%) | 0/99 (0%) | ||||
| COUGH | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 0/99 (0%) | ||||
| OROPHARYNGAL PAIN | 0/101 (0%) | 0/98 (0%) | 1/98 (1%) | 0/99 (0%) | ||||
| Vascular disorders | ||||||||
| HYPERTENSION | 0/101 (0%) | 1/98 (1%) | 0/98 (0%) | 0/99 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| GSKClinicalSupportHD@gsk.com |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT03494985
Other Study ID Numbers:
- 202902
- RH01986
First Posted:
Apr 11, 2018
Last Update Posted:
Sep 26, 2018
Last Verified:
Aug 1, 2018