Clinical trial NCT03494985: A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water
Official title: A Clinical Study to Evaluate the Efficacy of an Experimental Oralbalance Gel, Oral Rinse and Spray Versus Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-04-11
Enrollment: 422
Sex: ALL
Minimum age (years): 35
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)
timeFrame: At Day 29 of treatment (2 hours after supervised product use)
Secondary outcomes:
measure: Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29
timeFrame: At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use)
measure: Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1
timeFrame: At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use)
measure: Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)
timeFrame: At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use)
measure: Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8
timeFrame: At Day 8 (2 hours after supervised product use)
measure: Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)
timeFrame: At Day 8 and 29
measure: 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)
timeFrame: At Day 1 and 29
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: