ClinicalTrials.gg
Sign In
CompletedNCT03494985Updated Sep 26, 2018Results posted

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

An interventional study of Experimental Oralbalance Moisturizing Gel and Biotene Original Oral Rinse in Xerostomia, sponsored by GlaxoSmithKline. Completed. Open to participants aged 35 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-26.

Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 6 months after the study started (first participant enrolled Sep 2013, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
422
Allocation
Randomized
Ages
35 Years to 84 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Xerostomia

Browse trials for

03

In context

Xerostomia

286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.

This study's enrollment of 422 is above the median of 44 across 235 interventional studies indexed under Xerostomia.

Browse Xerostomia studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.

Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written 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 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

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 to the study materials (or closely related compounds) or any of their stated ingredients.
  • Participation in another clinical study or receipt of an 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
422 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • DeviceExperimental 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.

  • DeviceBiotene 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.

  • DeviceBiotene 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.

  • OtherWater

    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.

06

What researchers measure

Primary outcomes

  1. Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)

    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)

Secondary outcomes

  1. Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at 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 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)

  2. Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1

    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)

  3. Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)

    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)

  4. Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8

    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)

  5. Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)

    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

  6. 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)

    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

07

Results

Posted Jul 18, 2018

Participant flow

Participants were recruited from 2 sites in United States of America.

Participant flow — Overall Study
MilestoneOralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only Use
Started101989899
Completed96929294
Not completed5665
Withdrew: Adverse event3230
Withdrew: Other (withdrawal of consent)2325
Withdrew: Other (not specified)0110

Outcome measures

PrimaryModified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)

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)
Reported as:
Mean · Score on scale
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)
Score on scaleOralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only Use
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)2.7 ± 1.072.9 ± 0.992.6 ± 1.022.0 ± 0.95
Statistical analysis
  • OralBalance Moisturizing Gel vs Water Only Use · ANOVA · p = <0.0001 (p-value was adjusted using Dunnett's method for multiple comparisons) · Least square mean difference: 0.6 · 95% CI 0.4 to 0.9First named treatment minus second named treatment such that a positive value favours the first named treatment.
  • Oral Rinse vs Water Only Use · ANOVA · p = <0.0001 (p-value was adjusted using Dunnett's method for multiple comparisons) · Ls mean difference: 0.9 · 95% CI 0.6 to 1.2First named treatment minus second named treatment such that a positive value favours the first named treatment.
  • Moisturizing Mouth Spray vs Water Only Use · ANOVA · p = <0.0001 (p-value was adjusted using Dunnett's method for multiple comparisons.) · Ls mean difference: 0.6 · 95% CI 0.3 to 0.9First named treatment minus second named treatment such that a positive value favours the first named treatment.
SecondaryModified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at 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 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)
Reported as:
Mean · Score on scale
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29
Score on scaleOralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only Use
At 30 mins3.0 ± 0.943.2 ± 0.863.1 ± 1.002.3 ± 0.97
At 1 hour2.9 ± 0.973.2 ± 0.822.9 ± 0.972.2 ± 0.95
At 4 hours2.5 ± 1.112.7 ± 1.032.5 ± 1.021.9 ± 0.95
SecondaryModified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1

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)
Reported as:
Mean · Score on scale
Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1
Score on scaleOralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only Use
At 30 minutes2.8 ± 0.972.8 ± 0.812.7 ± 0.972.2 ± 0.97
At 1 hour2.8 ± 0.892.7 ± 0.812.7 ± 0.952.0 ± 0.94
At 2 hours2.6 ± 0.972.4 ± 0.892.5 ± 0.971.8 ± 0.86
At 4 hours2.4 ± 1.092.3 ± 1.062.3 ± 1.021.6 ± 0.88
SecondaryIndividual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)

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)
Reported as:
Mean · Score on scale
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Score on scaleOralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only Use
Q2 at Day 1, 30 minutes3.1 ± 0.923.0 ± 0.792.9 ± 1.002.5 ± 1.10
Q2 at Day 1, 1 hour2.9 ± 0.932.8 ± 0.822.8 ± 1.002.2 ± 1.03
Q2 at Day 1, 2 hours2.7 ± 0.972.5 ± 0.932.6 ± 0.992.0 ± 0.95
Q2 at Day 1, 4 hours2.4 ± 1.092.4 ± 1.052.4 ± 1.031.8 ± 0.94
Q2 at Day 29, 30 minutes3.0 ± 1.003.3 ± 0.853.2 ± 1.072.4 ± 0.97
Q2 at Day 29, 1 hour3.0 ± 0.873.2 ± 0.853.0 ± 1.002.3 ± 1.03
Q2 at Day 29. 2 hours2.7 ± 1.043.0 ± 0.932.8 ± 0.992.2 ± 1.01
Q2 at Day 29, 4 hours2.7 ± 1.062.8 ± 1.002.6 ± 1.072.0 ± 0.99
Q3 at Day 1, 30 minutes3.1 ± 0.973.0 ± 0.822.8 ± 1.022.3 ± 1.05
Q3 at Day 1, 1 hour2.8 ± 1.012.7 ± 0.782.7 ± 0.932.1 ± 1.07
Q3 at Day 1, 2 hours2.6 ± 1.002.4 ± 0.912.5 ± 0.981.9 ± 0.93
Q3 at Day 1, 4 hours2.3 ± 1.112.2 ± 1.002.3 ± 1.051.6 ± 0.86
Q3 at Day 29, 30 minutes3.0 ± 0.983.3 ± 0.873.1 ± 1.022.3 ± 0.99
Q3 at Day 29, 1 hour2.8 ± 1.013.2 ± 0.863.0 ± 1.042.2 ± 1.01
Q3 at Day 29. 2 hours2.7 ± 1.082.9 ± 0.972.7 ± 1.062.0 ± 1.02
Q3 at Day 29, 4 hours2.6 ± 1.042.6 ± 1.012.5 ± 1.082.0 ± 1.05
Q4 at Day 1, 30 minutes3.6 ± 0.883.4 ± 0.833.4 ± 0.943.0 ± 1.12
Q4 at Day 1, 1 hour3.3 ± 0.953.2 ± 0.753.1 ± 0.952.6 ± 1.05
Q4 at Day 1, 2 hours3.1 ± 0.932.9 ± 0.832.9 ± 0.882.4 ± 1.00
Q4 at Day 1, 4 hours2.9 ± 0.912.8 ± 0.922.8 ± 1.002.3 ± 0.99
Q4 at Day 29, 30 minutes3.3 ± 0.813.5 ± 0.843.4 ± 0.972.7 ± 1.02
Q4 at Day 29, 1 hour3.2 ± 0.873.4 ± 0.783.2 ± 0.952.6 ± 0.99
Q4 at Day 29. 2 hours3.1 ± 0.913.3 ± 0.873.0 ± 1.022.5 ± 0.97
Q4 at Day 29, 4 hours3.0 ± 1.023.0 ± 0.902.7 ± 1.012.3 ± 1.04
Q5 at Day 1, 30 minutes3.1 ± 1.083.0 ± 0.923.0 ± 1.132.5 ± 1.13
Q5 at Day 1, 1 hour2.8 ± 1.002.8 ± 0.832.9 ± 1.082.1 ± 1.11
Q5 at Day 1, 2 hours2.6 ± 1.072.4 ± 0.932.5 ± 1.021.9 ± 1.06
Q5 at Day 1, 4 hours2.3 ± 1.102.2 ± 1.042.2 ± 1.101.6 ± 0.91
Q5 at Day 29, 30 minutes3.1 ± 0.953.3 ± 0.933.1 ± 1.032.4 ± 1.00
Q5 at Day 29, 1 hour2.9 ± 1.093.1 ± 0.922.9 ± 1.042.2 ± 1.06
Q5 at Day 29. 2 hours2.7 ± 1.062.9 ± 0.942.7 ± 1.102.1 ± 1.00
Q5 at Day 29, 4 hours2.6 ± 1.102.6 ± 0.982.4 ± 1.092.0 ± 1.00
Q6 at Day 1, 30 minutes3.1 ± 1.063.0 ± 0.862.9 ± 1.122.4 ± 1.18
Q6 at Day 1, 1 hour2.8 ± 1.062.7 ± 0.892.8 ± 1.092.0 ± 1.06
Q6 at Day 1, 2 hours2.6 ± 1.022.4 ± 0.942.4 ± 1.051.8 ± 0.98
Q6 at Day 1, 4 hours2.2 ± 1.082.2 ± 1.052.1 ± 1.071.6 ± 0.86
Q6 at Day 29, 30 minutes3.1 ± 1.013.3 ± 0.923.1 ± 1.072.3 ± 1.04
Q6 at Day 29, 1 hour2.9 ± 1.093.0 ± 0.943.0 ± 1.042.2 ± 1.04
Q6 at Day 29. 2 hours2.7 ± 1.082.9 ± 0.942.7 ± 1.102.0 ± 0.99
Q6 at Day 29, 4 hours2.6 ± 1.142.5 ± 0.972.4 ± 1.092.0 ± 0.98
Q7 at Day 1, 30 minutes2.8 ± 1.023.3 ± 0.923.2 ± 1.101.8 ± 1.06
Q7 at Day 1, 1 hour2.5 ± 0.992.9 ± 0.802.7 ± 1.021.7 ± 1.06
Q7 at Day 1, 2 hours2.4 ± 1.122.4 ± 0.852.4 ± 1.041.6 ± 0.91
Q7 at Day 1, 4 hours2.1 ± 1.022.2 ± 0.982.1 ± 1.061.5 ± 0.89
Q7 at Day 29, 30 minutes2.8 ± 1.123.2 ± 0.843.0 ± 1.162.0 ± 1.04
Q7 at Day 29, 1 hour2.7 ± 1.193.0 ± 0.892.7 ± 1.081.9 ± 1.03
Q7 at Day 29. 2 hours2.5 ± 1.182.7 ± 1.032.4 ± 1.131.8 ± 0.98
Q7 at Day 29. 4 hours2.4 ± 1.202.5 ± 1.112.2 ± 1.121.7 ± 0.91
Q8 at Day 1, 30 minutes2.8 ± 0.993.0 ± 0.922.9 ± 1.182.2 ± 1.12
Q8 at Day 1, 1 hour2.8 ± 1.002.7 ± 0.882.6 ± 1.012.0 ± 1.08
Q8 at Day 1, 2 hours2.5 ± 1.132.3 ± 0.932.4 ± 0.971.7 ± 0.90
Q8 at Day 1, 4 hours2.2 ± 1.072.2 ± 1.062.2 ± 1.041.6 ± 0.94
Q8 at Day 29, 30 minutes3.0 ± 1.003.3 ± 0.953.0 ± 1.092.2 ± 0.98
Q8 at Day 29, 1 hour2.9 ± 1.053.1 ± 0.942.8 ± 1.112.1 ± 1.03
Q8 at Day 29. 2 hours2.6 ± 1.042.9 ± 0.992.6 ± 1.062.0 ± 0.97
Q8 at Day 29. 4 hours2.5 ± 1.092.6 ± 1.022.3 ± 1.132.0 ± 1.02
Q9 at Day 1, 30 minutes3.0 ± 0.963.1 ± 0.842.9 ± 1.132.3 ± 1.10
Q9 at Day 1, 1 hour2.8 ± 0.922.8 ± 0.802.7 ± 1.012.1 ± 1.04
Q9 at Day 1, 2 hours2.6 ± 1.012.5 ± 0.872.5 ± 1.001.9 ± 0.95
Q9 at Day 1, 4 hours2.4 ± 1.112.3 ± 1.042.2 ± 0.981.7 ± 0.85
Q9 at Day 29, 30 minutes3.0 ± 1.053.3 ± 0.903.1 ± 1.032.3 ± 1.03
Q9 at Day 29, 1 hour2.9 ± 1.033.1 ± 0.903.0 ± 1.022.3 ± 1.01
Q9 at Day 29. 2 hours2.6 ± 1.072.9 ± 0.932.7 ± 1.072.0 ± 0.98
Q9 at Day 29. 4 hours2.6 ± 1.112.7 ± 0.962.4 ± 1.072.0 ± 1.01
Q10 at Day 1, 30 minutes3.1 ± 0.953.2 ± 0.853.1 ± 1.072.6 ± 1.18
Q10 at Day 1, 1 hour2.9 ± 0.923.0 ± 0.743.0 ± 0.962.3 ± 1.03
Q10 at Day 1, 2 hours2.8 ± 1.052.7 ± 0.862.7 ± 0.932.2 ± 1.00
Q10 at Day 1, 4 hours2.8 ± 0.992.6 ± 1.052.5 ± 1.082.1 ± 1.05
Q10 at Day 29, 30 minutes3.2 ± 0.923.5 ± 0.813.2 ± 1.022.4 ± 0.99
Q10 at Day 29, 1 hour3.0 ± 1.013.3 ± 0.793.0 ± 0.992.4 ± 0.94
Q10 at Day 29. 2 hours2.9 ± 1.053.1 ± 0.832.8 ± 1.022.3 ± 0.95
Q10 at Day 29. 4 hours2.8 ± 1.082.9 ± 0.922.7 ± 1.032.2 ± 1.02
Q11 at Day 1, 30 minutes3.0 ± 0.913.1 ± 0.943.1 ± 1.082.4 ± 1.18
Q11 at Day 1, 1 hour2.8 ± 0.912.9 ± 0.892.8 ± 1.062.2 ± 1.01
Q11 at Day 1, 2 hours2.6 ± 1.012.6 ± 0.922.4 ± 0.982.0 ± 1.02
Q11 at Day 1, 4 hours2.5 ± 1.092.4 ± 1.052.3 ± 1.051.9 ± 0.96
Q11 at Day 29, 30 minutes3.1 ± 0.973.3 ± 0.943.2 ± 0.992.4 ± 1.03
Q11 at Day 29, 1 hour2.9 ± 0.923.1 ± 0.903.0 ± 0.982.3 ± 1.01
Q11 at Day 29, 2 hours2.7 ± 0.992.9 ± 0.942.7 ± 1.062.1 ± 0.96
Q11 at Day 29. 4 hours2.6 ± 1.052.7 ± 0.942.5 ± 1.092.1 ± 0.97
Q12 at Day 1, 30 minutes2.6 ± 1.163.1 ± 1.012.9 ± 1.212.2 ± 1.25
Q12 at Day 1, 1 hour2.3 ± 1.122.7 ± 1.012.5 ± 1.032.0 ± 1.26
Q12 at Day 1, 2 hours2.2 ± 1.072.1 ± 0.912.1 ± 0.991.7 ± 0.94
Q12 at Day 1, 4 hours1.9 ± 0.962.0 ± 0.972.0 ± 0.921.6 ± 0.93
Q12 at Day 29, 30 minutes2.8 ± 1.123.1 ± 0.962.9 ± 1.102.1 ± 0.98
Q12 at Day 29, 1 hour2.5 ± 1.112.8 ± 0.972.6 ± 1.112.0 ± 0.95
Q12 at Day 29. 2 hours2.3 ± 1.122.6 ± 0.992.3 ± 1.151.7 ± 0.87
Q12 at Day 29. 4 hours2.3 ± 1.182.3 ± 1.062.1 ± 1.071.7 ± 0.91
SecondaryIndividual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8

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)
Reported as:
Mean · Score on scale
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Score on scaleOralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only Use
Q1 at Day 8, 2 hours2.8 ± 0.983.0 ± 0.862.9 ± 0.862.1 ± 0.92
Q2 at Day 8, 2 hours2.9 ± 0.973.0 ± 0.793.0 ± 1.002.2 ± 0.98
Q3 at Day 8, 2 hours2.8 ± 1.042.9 ± 0.762.8 ± 0.972.0 ± 0.92
Q4 at Day 8, 2 hours3.3 ± 0.893.2 ± 0.753.2 ± 0.972.5 ± 1.00
Q5 at Day 8, 2 hours2.8 ± 1.003.0 ± 0.932.9 ± 1.072.1 ± 1.04
Q6 at Day 8, 2 hours2.8 ± 0.982.9 ± 0.902.8 ± 1.112.0 ± 1.09
Q7 at Day 8, 2 hours2.6 ± 1.092.9 ± 0.842.6 ± 1.021.5 ± 0.84
Q8 at Day 8, 2 hours2.7 ± 1.002.9 ± 0.902.7 ± 1.071.9 ± 0.94
Q9 at Day 8, 2 hours2.8 ± 0.972.9 ± 0.812.8 ± 1.072.1 ± 0.98
Q10 at Day 8, 2 hours3.0 ± 0.923.2 ± 0.773.0 ± 0.992.4 ± 1.01
Q11 at Day 8, 2 hours2.9 ± 0.903.0 ± 0.812.8 ± 1.022.1 ± 1.02
Q12 at Day 8, 2 hours2.3 ± 1.102.7 ± 0.842.4 ± 1.031.7 ± 0.91
SecondaryIndividual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)

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
Reported as:
Mean · Score on scale
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Score on scaleOralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only Use
Q1 at Day 82.5 ± 0.962.7 ± 0.932.6 ± 1.002.2 ± 0.91
Q1 at Day 292.7 ± 1.113.0 ± 0.932.8 ± 1.182.2 ± 1.08
Q2 at Day 82.7 ± 0.952.9 ± 0.832.8 ± 0.942.1 ± 0.95
Q2 at Day 293.1 ± 1.063.2 ± 0.962.9 ± 1.182.3 ± 1.20
Q3 at Day 82.5 ± 0.942.8 ± 0.902.6 ± 0.991.9 ± 1.02
Q3 at Day 292.7 ± 1.093.0 ± 1.082.6 ± 1.182.1 ± 1.12
Q4 at Day 82.6 ± 0.972.7 ± 0.892.6 ± 0.981.9 ± 0.90
Q4 at Day 292.8 ± 1.153.1 ± 1.072.8 ± 1.072.2 ± 1.08
Q5 at Day 82.6 ± 0.982.8 ± 0.932.5 ± 1.001.9 ± 0.91
Q5 at Day 292.8 ± 1.113.0 ± 1.062.8 ± 1.112.0 ± 1.06
Q6 at Day 82.6 ± 1.002.8 ± 0.942.5 ± 0.921.9 ± 1.00
Q6 at Day 292.8 ± 1.153.0 ± 1.082.8 ± 1.122.1 ± 1.11
SecondaryArea Under Curve (AUC) up to 4 Hours After Treatment- Response of All Question of the Modified Product Performance and Attributes Questionnaire I (PPAQ I)

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
Reported as:
Mean · Scores on scale/seconds
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)
Scores on scale/secondsOralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only Use
Q1, AUC At Day 12.6 ± 0.882.5 ± 0.792.5 ± 0.851.9 ± 0.79
Q1, AUC At Day 292.7 ± 0.962.9 ± 0.882.7 ± 0.932.0 ± 0.89
Q2, AUC At Day 12.7 ± 0.882.6 ± 0.802.6 ± 0.832.0 ± 0.87
Q2, AUC At Day 292.8 ± 0.933.0 ± 0.852.8 ± 0.922.2 ± 0.95
Q3, AUC At Day 12.6 ± 0.932.5 ± 0.752.5 ± 0.861.9 ± 0.85
Q3, AUC At Day 292.7 ± 0.972.9 ± 0.862.7 ± 0.942.1 ± 0.96
Q4, AUC At Day 13.1 ± 0.783.0 ± 0.732.9 ± 0.782.5 ± 0.95
Q4, AUC At Day 293.1 ± 0.853.2 ± 0.793.0 ± 0.882.5 ± 0.95
Q5, AUC At Day 12.6 ± 0.942.5 ± 0.792.5 ± 0.931.9 ± 0.91
Q5, AUC At Day 292.7 ± 0.992.9 ± 0.862.7 ± 0.982.1 ± 0.95
Q6, AUC At Day 12.6 ± 0.902.4 ± 0.802.5 ± 0.931.8 ± 0.88
Q6, AUC At Day 292.8 ± 1.012.9 ± 0.862.7 ± 0.982.1 ± 0.93
Q7, AUC At Day 12.4 ± 0.942.5 ± 0.752.5 ± 0.931.6 ± 0.93
Q7, AUC At Day 292.6 ± 1.102.8 ± 0.922.5 ± 1.031.8 ± 0.94
Q8, AUC At Day 12.5 ± 0.942.4 ± 0.802.4 ± 0.871.8 ± 0.86
Q8, AUC At Day 292.7 ± 0.982.9 ± 0.892.6 ± 0.982.0 ± 0.94
Q9, AUC At Day 12.6 ± 0.882.6 ± 0.752.5 ± 0.861.9 ± 0.84
Q9, AUC At Day 292.7 ± 1.002.9 ± 0.842.7 ± 0.962.1 ± 0.93
Q10, AUC At Day 12.8 ± 0.822.7 ± 0.692.7 ± 0.852.2 ± 0.95
Q10, AUC At Day 292.9 ± 0.963.1 ± 0.772.9 ± 0.912.3 ± 0.93
Q11, AUC At Day 12.6 ± 0.892.6 ± 0.812.5 ± 0.892.0 ± 0.89
Q11, AUC At Day 292.8 ± 0.922.9 ± 0.852.8 ± 0.952.2 ± 0.92
Q12, AUC At Day 12.2 ± 0.962.3 ± 0.792.2 ± 0.871.8 ± 0.96
Q12, AUC At Day 292.4 ± 1.062.6 ± 0.902.4 ± 1.011.8 ± 0.86

Adverse events

Collected over Approximately 29 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
OralBalance Moisturizing Gel0/101 (0%)0/101 (0%)17/101 (16.8%)
Oral Rinse0/98 (0%)1/98 (1%)21/98 (21.4%)
Moisturizing Mouth Spray0/98 (0%)2/98 (2%)12/98 (12.2%)
Water Only Use0/99 (0%)0/99 (0%)20/99 (20.2%)
Most frequent serious events
Most frequent serious events
EventOralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only Use
CARDIAC ARRESTCardiac disorders0/1011/980/980/99
DIVERTICULITISInfections and infestations0/1010/981/980/99
OVARIAN CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1010/981/980/99
Most frequent other events
Showing 10 of 44
Most frequent other events
EventOralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only Use
TRAUMATIC ULCERInjury, poisoning and procedural complications3/1013/980/980/99
NASOPHARYNGITISInfections and infestations0/1013/981/981/99
TONGUE COATEDGastrointestinal disorders1/1013/982/981/99
ORAL HERPESInfections and infestations2/1011/980/983/99
TOOTH FRACTUREInjury, poisoning and procedural complications1/1010/980/982/99
DEVICE FAILUREGeneral disorders0/1010/980/982/99
CONTUSIONInjury, poisoning and procedural complications0/1010/981/980/99
FALLInjury, poisoning and procedural complications0/1010/981/980/99
MOUTH INJURYInjury, poisoning and procedural complications0/1010/981/981/99
COUGHRespiratory, thoracic and mediastinal disorders0/1011/980/980/99

Baseline characteristics

Age, Continuous
Age, Continuous(Years)OralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only UseTotal
Geometric mean56.2 ± 10.1952.6 ± 10.8754.0 ± 9.8052.7 ± 9.6153.9 ± 10.20
Sex: Female, Male
Sex: Female, Male(Participants)OralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only UseTotal
Female73747978304
Male2824192192
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)OralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only UseTotal
Hispanic or Latino61171640
Not Hispanic or Latino95879183356
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)OralBalance Moisturizing GelOral RinseMoisturizing Mouth SprayWater Only UseTotal
American Indian or Alaska Native02002
Asian21227
Native Hawaiian or Other Pacific Islander00000
Black or African American1317161359
White85778084326
More than one race11002
Unknown or Not Reported00000
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2013 to primary completion in Jan 2014, 3 months.

Results were first posted in Jul 2018, 4 years 6 months after primary completion.

Of 101 interventional studies with no phase under Xerostomia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 33. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2018
First posted
Apr 11, 2018
StartActual
Sep 17, 2013
Primary completionActual
Jan 10, 2014
CompletionActual
Jan 10, 2014
Results first posted
Jul 18, 2018
Last update
Sep 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03494985
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 11, 2018
Start date
Sep 17, 2013
Primary completion
Jan 10, 2014
Completion
Jan 10, 2014
Results posted
Jul 18, 2018
Last update
Sep 26, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Xerostomia →

Other studies from this sponsor

GlaxoSmithKline →

Start the discussion