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

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ClinicalTrials.gov Identifier: NCT03494985
Recruitment Status : Completed
First Posted : April 11, 2018
Results First Posted : July 18, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE April 5, 2018
First Posted Date  ICMJE April 11, 2018
Results First Submitted Date  ICMJE June 25, 2018
Results First Posted Date  ICMJE July 18, 2018
Last Update Posted Date September 26, 2018
Actual Study Start Date  ICMJE September 17, 2013
Actual Primary Completion Date January 10, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
Modifed 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.
Change History Complete list of historical versions of study NCT03494985 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • 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) ]
    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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • Modifed 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) ]
    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.
  • Modifed 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) ]
    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.
  • Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 2-12 [ Time Frame: 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.
  • Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8 [ Time Frame: 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.
  • Modified Product Performance and Attributes Questionnaire II (PPAQ II) [ Time Frame: 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 to the modified Product Performance and Attributes Questionnaire I (PPAQ I) [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water
Official Title  ICMJE A Clinical Study to Evaluate the Efficacy of an Experimental Oralbalance Gel, Oral Rinse and Spray Versus Water
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Xerostomia
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Other: Water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2018)
422
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 10, 2014
Actual Primary Completion Date January 10, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03494985
Other Study ID Numbers  ICMJE 202902
RH01986 ( Other Identifier: GSK )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP