NCT02641912

Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms

A Clinical Study to Evaluate the Efficacy of an Experimental Mouthwash Formulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a single center, 7-day, examiner blind, two treatment-arm, randomized, stratified (Sjogren's Syndrome status \[Y/N\]), parallel group study conducted in participants experiencing dry mouth symptoms. This study is designed to investigate the effect of an experimental mouthwash formulation in providing relief of dry mouth symptoms.

Conditions

• Xerostomia

Interventions

Type	Name	Description
OTHER	Biotene mouthwash	During supervised product use: Participants will rinse with 15 mls of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage is permitted. At Home use:Participants will rinse with 15 mls of mouthwash for 30 seconds and spit out. A maximum of two doses can be used per day.
OTHER	Mineral Water	During supervised product use:Participants will take a dose (drink) of one measured sip of 15mls of water. At Home use: Participants can sip (drink) water as often as required. Participants will be consuming their own water for home use.

Timeline

• Start date: 2016-03-09
• Primary completion: 2016-04-15
• Completion: 2016-04-15
• First posted: 2015-12-30
• Last updated: 2017-07-11
• Results posted: 2017-01-27

Locations

1 site across 1 country: United States