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

NCT03494985 | Completed Results

• 2 other identifiers: 202902RH01986
• Study Type: interventional
• Target: 422
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

• Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)

  Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 2 hours after supervised product use on Day 29 of treatment.

  At Day 29 of treatment (2 hours after supervised product use)

Secondary Outcomes (6)

• Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29

  At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use)

• Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1

  At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use)

• Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)

  At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use)

• Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8

  At Day 8 (2 hours after supervised product use)

• Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)

  At Day 8 and 29

Study Arms (4)

OralBalance moisturizing gel

EXPERIMENTAL

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

Device: Experimental Oralbalance Moisturizing Gel

Oral rinse

EXPERIMENTAL

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

Device: Biotene Original Oral Rinse

Moisturizing mouth spray

EXPERIMENTAL

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

Device: Biotene Moisturizing Mouth Spray

Water only use

SHAM COMPARATOR

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

Other: Water

Interventions

Experimental Oralbalance Moisturizing Gel 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.

OralBalance moisturizing gel

Biotene Original Oral Rinse 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.

Oral rinse

Biotene Moisturizing Mouth Spray 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.

Moisturizing mouth spray

Water 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.

Water only use

Eligibility Criteria

• Age: 35 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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'.

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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Xerostomia

Interventions

Water

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

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
• Masking Details: The examiner and site staff reviewing the efficacy assessments were blinded to the treatment allocation of participants. All other study personnel (study statistician, data management staff and other employees of the Sponsor who may influence study outcomes) were blinded to the study treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 11, 2018
• Study Start: September 17, 2013
• Primary Completion: January 10, 2014
• Study Completion: January 10, 2014
• Last Updated: September 26, 2018
• Results First Posted: July 18, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share