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Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms

NCT02641912 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-07-11

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-09
Primary Completion
2016-04-15
Completion
2016-04-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02641912 on ClinicalTrials.gov