A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water

NCT ID: NCT03494985

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-17
• Study Completion Date: 2014-01-10

Brief Summary

This study assessed the efficacy of three dry mouth products (including an experimental Oralbalance gel, oral rinse, and moisturizing spray) to relieve the feeling of dry mouth compared to water, in dry mouth population over a period of 28 days.

Detailed Description

This was a multi-centered (two-sites), examiner-blinded, four treatment arms, stratified (by Modified Dry Mouth Inventory [DMI] score), randomized, parallel group study in participants with self-reported dry mouth symptoms as determined by participant responses to the DMI. Participants used their assigned dry mouth treatment at home for 28 days.

Conditions

Xerostomia

Study Design

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

Study Groups

OralBalance moisturizing gel

All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits.

Group Type: EXPERIMENTAL

Experimental Oralbalance Moisturizing Gel

Intervention Type: DEVICE

Participants placed approximately a half inch length of the gel onto the tongue and spread thoroughly using their tongue. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.

Oral rinse

All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits.

Group Type: EXPERIMENTAL

Biotene Original Oral Rinse

Intervention Type: DEVICE

Participants rinsed their mouth with 15 milliliters (mL) of oral rinse for 30 seconds and spat out. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.

Moisturizing mouth spray

All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits.

Group Type: EXPERIMENTAL

Biotene Moisturizing Mouth Spray

Intervention Type: DEVICE

Participants sprayed one jet directly into their mouth. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.

Water only use

All the participants in this arm used water as instructed under the supervision of trained site staff on their visits.

Group Type: SHAM_COMPARATOR

Water

Intervention Type: OTHER

Participants were allowed to take only one measured sip of water (15 mL) 30 minutes before the supervised product use. After the supervised treatment at the site, participants assigned to the water only treatment were allowed to sip water as often as required.

Interventions

Experimental Oralbalance Moisturizing Gel

Participants placed approximately a half inch length of the gel onto the tongue and spread thoroughly using their tongue. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.

Intervention Type: DEVICE

Biotene Original Oral Rinse

Participants rinsed their mouth with 15 milliliters (mL) of oral rinse for 30 seconds and spat out. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.

Intervention Type: DEVICE

Biotene Moisturizing Mouth Spray

Participants sprayed one jet directly into their mouth. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.

Intervention Type: DEVICE

Water

Participants were allowed to take only one measured sip of water (15 mL) 30 minutes before the supervised product use. After the supervised treatment at the site, participants assigned to the water only treatment were allowed to sip water as often as required.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Understands and is willing, able and likely to comply with all study procedures and restrictions.
• Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination., b) Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements. Subjects with stable and controlled medical conditions with no overt medical conditions which would contraindicate participation (in the opinion of the Investigator or medically qualified designee) which would interfere with the conduct of the study.
• Self reported feeling of a dry mouth according to the modified DMI questions. Subject must answer at least 3 out of 5 questions with 'agree a little', 'agree' or 'strongly agree'.

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.
• 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 or receipt of an investigational drug within 30 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.
• Subject works in one of the following: Advertising, Journalism, Public Relations, Manufacturing, retail or distribution of medicines, medical devices or healthcare products, Market Research or Marketing.
• Use of prescription systemic parasympathetic medications (e.g. Pilocarpine), for the treatment of the feeling of dry mouth.
• At the discretion of the examiner, subjects currently under the care of a dental/medical professional specifically for the treatment of dry mouth.
• Evidence of gross intra-oral neglect or need for extensive dental therapy.
• Denture wearer (partial or complete dentures).
• Subject with dental implants.
• Subjects with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration).
• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 84 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

Other Identifiers

RH01986

Identifier Type: OTHER

Identifier Source: secondary_id

202902

Identifier Type: -

Identifier Source: org_study_id