XerostomiaNCT03494985
A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water
A study testing Experimental Oralbalance Moisturizing Gel, Biotene Original Oral Rinse and Biotene Moisturizing Mouth Spray in people with Xerostomia, run by GlaxoSmithKline.
Trial 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 more about this study
- Who is it for?
- Ages 35 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Xerostomia
- What is being tested?
- Experimental Oralbalance Moisturizing Gel, Biotene Original Oral Rinse and Biotene Moisturizing Mouth Spray
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2013to 10 Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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'.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
About this study
Official title: A Clinical Study to Evaluate the Efficacy of an Experimental Oralbalance Gel, Oral Rinse and Spray Versus Water
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.
- Conditions
- Xerostomia
- Being tested
- Experimental Oralbalance Moisturizing Gel, Biotene Original Oral Rinse, Biotene Moisturizing Mouth Spray, Water
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Oralbalance Moisturizing GelDevice
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.
Biotene Original Oral RinseDevice
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.
Biotene Moisturizing Mouth SprayDevice
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.
WaterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| OralBalance moisturizing gel | Experimental | All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits. Receives: Device: Experimental Oralbalance Moisturizing Gel |
| Oral rinse | Experimental | All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits. Receives: Device: Biotene Original Oral Rinse |
| Moisturizing mouth spray | Experimental | All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits. Receives: Device: Biotene Moisturizing Mouth Spray |
| Water only use | Sham comparator | All the participants in this arm used water as instructed under the supervision of trained site staff on their visits. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Day 29 of treatment (2 hours after supervised product use)
Secondary outcomes (6)
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.
Measured: At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use)
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.
Measured: At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use)
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.
Measured: At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use)
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.
Measured: At Day 8 (2 hours after supervised product use)
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.
Measured: At Day 8 and 29
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.
Measured: At Day 1 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start17 Sep 2013
- Primary completion10 Jan 2014
- Study completion10 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494985
- Sponsor's protocol ID
- 202902
- Other IDs
- RH01986
- Status last verified
- Aug 2018
- First submitted
- 5 Apr 2018
- Last updated
- 26 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Efficacy of an Experimental Oralbalance Gel, Oral Rinse and Spray Versus Water
- ClinicalTrials.gov ID
- NCT03494985
- Acronym / sponsor ID
- 202902
- Conditions
- Xerostomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2013 (actual)
- Primary completion
- 10 Jan 2014 (actual)
- Study completion
- 10 Jan 2014 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Posted 18 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OralBalance moisturizing gel | Experimental | Device: Experimental Oralbalance Moisturizing GelAll the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits. |
| Oral rinse | Experimental | Device: Biotene Original Oral RinseAll the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits. |
| Moisturizing mouth spray | Experimental | Device: Biotene Moisturizing Mouth SprayAll 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 | Sham comparator | Other: WaterAll the participants in this arm used water as instructed under the supervision of trained site staff on their visits. |
Who may qualify
- Ages
- 35 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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'.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Oralbalance Moisturizing GelParticipants 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. | Device | OralBalance moisturizing gel |
| Biotene Original Oral RinseParticipants 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. | Device | Oral rinse |
| Biotene Moisturizing Mouth SprayParticipants 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. | Device | Moisturizing mouth spray |
| WaterParticipants 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. | Other | Water only use |
Primary outcome
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)
Time frame: 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.
6 secondary outcomes
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29
Time frame: At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use)
Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1
Time frame: At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use)
Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
Time frame: At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use)
Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
Time frame: At Day 8 (2 hours after supervised product use)
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
Time frame: At Day 8 and 29
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)
Time frame: At Day 1 and 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Oralbalance Moisturizing Gel, Biotene Original Oral Rinse and Biotene Moisturizing Mouth Spray in people with Xerostomia, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth) (time frame: At Day 29 of treatment (2 hours after supervised product use)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.