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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Xerostomia

Treatments: Device: Biotene Original Oral Rinse; Device: Experimental Oralbalance Moisturizing Gel; Device: Biotene Moisturizing Mouth Spray; Other: Water

Study type: Interventional

Funder types: Industry

Identifiers

NCT03494985

202902

RH01986 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 422 patients

Sex: All

Ages: 35 to 84 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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422 participants in 4 patient groups

OralBalance moisturizing gel

Experimental group

Description:

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

Treatment:

Device: Experimental Oralbalance Moisturizing Gel

Oral rinse

Experimental group

Description:

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

Treatment:

Device: Biotene Original Oral Rinse

Moisturizing mouth spray

Experimental group

Description:

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

Treatment:

Device: Biotene Moisturizing Mouth Spray

Water only use

Sham Comparator group

Description:

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

Treatment:

Other: Water