Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms

NCT02641912 | Completed Results

• 1 other identifier: 204870
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in Product Performance and Attributes Questionnaire 3 (PPAQ3) at 120 Minutes(Mins) Post Treatment on Day 8

  Participants answered question 1 'Relieving the discomfort of dry mouth' in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

  120 mins post treatment on Day 8

Secondary Outcomes (31)

• Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in Product Performance And Attributes Questionnaire 2 (PPAQ2) at 30 Mins Post Treatment on Day 8

  30 mins post treatment on Day 8

• Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8

  60 and 240 mins post treatment on Day 8

• Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8

  5 mins post treatment on Day 8

• Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8

  30 mins post treatment on Day 8

• Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8

  60 mins. post treatment on Day 8

Study Arms (2)

Experimental Mouthwash

EXPERIMENTAL

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: Biotene mouthwash

Mineral Water

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.

Other: Mineral Water

Interventions

Biotene mouthwash 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.

Experimental Mouthwash

Mineral Water 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.

Mineral Water

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Xerostomia

Interventions

Mineral Waters

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: December 30, 2015
• Study Start: March 9, 2016
• Primary Completion: April 15, 2016
• Study Completion: April 15, 2016
• Last Updated: July 11, 2017
• Results First Posted: January 27, 2017

Record last verified: 2017-06

Locations

US (1)