Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641912
• Other study ID #: 204870
• Status: Completed
• Phase: N/A
• First received: December 24, 2015
• Last updated: May 26, 2016
• Start date: March 2016
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Xerostomia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to the question 'Relieving the discomfort of dry mouth' in Product Performance Attribute Questionnaire 3 (PPAQ3) at 120 mins post treatment on Day 8		120 mins post treatment on Day 8	No
Secondary	Response to the question 'Relieving the discomfort of dry mouth' in Product Performance Attribute Questionnaire 2 ( PPAQ2) at 30 mins post treatment on Day 8		30 mins post treatment on Day 8	No
Secondary	Response to the question '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	No
Secondary	Response to Product Performance Attribute Questionnaire1( PPAQ1) at 5 mins post treatment on Day 8		5 mins post treatment on Day 8	No
Secondary	Response to other questions from PPAQ2 at 30 mins post treatment on Day 8		30 mins post treatment on Day 8	No
Secondary	Response to other questions from PPAQ3 at 60, 120 and 240 mins post treatment on Day 8		60, 120 and 240 mins post treatment on Day 8	No
Secondary	Response to Product Performance Attribute Questionnaire 4( PPAQ4) prior to treatment on Day 8		prior to treatment on Day 8	No
Secondary	Response to PPAQ1 at 5 mins post treatment on Day 1		5 mins post treatment on Day 1	No
Secondary	Response to PPAQ2 at 30 mins post treatment on Day 1		30 mins post treatment on Day 1	No
Secondary	Response to PPAQ3 at 60, 120 and 240 mins post treatment on Day 1		60, 120 and 240 mins post treatment on Day 1	No
Secondary	Response to PPAQ1 at 5mins post treatment on Day 3		5mins post treatment on Day 3	No
Secondary	Response to PPAQ2 at 30mins post treatment on Day 3		30mins post treatment on Day 3	No
Secondary	Response to PPAQ3 at 60, 120 and 240mins post treatment on Day 3		60, 120 and 240mins post treatment on Day 3	No
Secondary	Response to PPAQ4 prior to treatment on Day 3		Prior to treatment on Day 3	No
Secondary	Response to Subjective Assessment of Patient's Quality of Life (SAoP QoL)1 on Day 1		Day 1	No
Secondary	Response to SAoP QoL1 on Day 8		Day 8	No
Secondary	Responses to Dry Mouth Inventory Quality of Life (DMI QoL) on Day 1		Day 1	No
Secondary	Responses to DMI QoL on Day 8		Day 8	No
Secondary	Responses to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1		Day 1	No
Secondary	Responses to PPUSQ on Day 3		Day 3	No
Secondary	Responses to PPUSQ on Day 8		Day 8	No