At a glance

ClinicalIndex Comparison Record

N/ACompleted· 100 enrolled

Drug / intervention

Biotene mouthwash +1 moreother

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02641912

NCT02641912N/ACompleted

Compare CT.gov

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

GlaxoSmithKline·interventional·Posted Dec 30, 2015·Updated Jul 11, 2017

In Brief

A clinical study evaluating Biotene mouthwash and Mineral Water for Xerostomia. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsXerostomia

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

20162017201820192020202120222023202420252026

First PostedDec 2015

Enrollment StartMar 2016

Primary CompletionApr 2016

TodayJul 2026

First PostedDec 30, 2015

Enrollment StartMar 9, 2016

Primary CompletionApr 15, 2016

TodayJul 2, 2026

Enrollment to primary: 1 monthPosted 10.5 years ago

Interventions

Biotene mouthwashother

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.

Mineral Waterother

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.