Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms

NCT ID: NCT02641912

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-09
• Study Completion Date: 2016-04-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental 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.

Group Type: EXPERIMENTAL

Biotene mouthwash

Intervention Type: OTHER

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 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.

Group Type: OTHER

Mineral Water

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
• Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination
• Subject with stable and controlled condition with no overt medical conditions which would contraindicate participation (in the opinion of the Investigator or medically qualified designee) and no clinically significant and relevant abnormalities of medical history or oral examination which would interfere with the conduct of the study
• All subjects should report having a feeling of a dry mouth according to the DMSQ. (Subject must answer at least 2 out of the 4 questions with 'agree a little', 'agree' or 'strongly agree'
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 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
• Subjects with Sjögren's Syndrome along with reporting having a feeling of dry mouth according to the DMSQ, should also have a confirmed diagnosis of their condition as shown by a positive salivary gland biopsy or SS-A (anti-Ro antibody) or SS-B (La antibody) or a letter from a physician if diagnosis was made more than 3 years ago OR Subjects reporting having a feeling of dry mouth due to other diseases or conditions excluding Sjögren's Syndrome
• Understands and is willing, able and likely to comply with all study procedures and restrictions.

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
• 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
• Subjects with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration)
• Evidence of gross intra-oral neglect or need for extensive dental therapy

-. Denture wearer (complete dentures)

• Subjects not on stable doses of prescription systemic parasympathetic medications (e.g. Pilocarpine), for the treatment of the feeling of dry mouth
• 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 (including cosmetic studies) or receipt of an investigational drug within 14 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

204870

Identifier Type: -

Identifier Source: org_study_id