A Clinical Study to Evaluate the Efficacy of an Experimental Oralbalance Gel, Oral Rinse and Spray Versus Water

GlaxoSmithKline0 sites422 target enrollmentSeptember 17, 2013

ConditionsXerostomia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Xerostomia
Sponsor: GlaxoSmithKline
Enrollment: 422
Primary Endpoint: Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 17, 2013

End Date

January 10, 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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))
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))
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))
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))
Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)(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)(At Day 1 and 29)