Clinical trial NCT03005041: Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects
Official title: A Clinical Study Evaluating the Consumer Perception of an Experimental Mouthwash Formulation After a Single Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-12-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth


Eligibility criteria: 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
* Aged 18 - 84 years inclusive
* 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
* Participant reports having a feeling of a dry mouth according to the Dry Mouth Screening Questionnaire (DMSQ) (Subject must answer at least 2 out of the 4 questions with 'agree a little', 'agree' or 'strongly agree' at the Screening Visit (Visit 1). Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min at the Screening Visit (Visit 1).
* Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min ATH the Screening Visit (Visit 1).
* 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 or have a positive urine pregnancy test at the Screening Visit
* Women who are breast-feeding
* Participant is currently undergoing radiotherapy and/or chemotherapy treatment
* Any condition the investigator identifies that can confound the participant's ability to properly participate in the study e.g. Alzheimer's Disease
* Participant 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)
* Participant 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 clinical study team or members of their immediate family. Students and employees of the Tufts University School of Dental Medicine not associated with the clinical trials team are eligible to participate. Students and employees will not be specifically targeted for enrollment
* Non-English speaking Participants will not be enrolled in the study. Participants must be able to read and write in English

Primary outcomes:
measure: Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
timeFrame: Within 2 minutes post product use
Secondary outcomes:
measure: Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
timeFrame: Within 2 minutes post product use
measure: Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
timeFrame: Within 30 ± 5 minutes post product use
measure: Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
timeFrame: Within 5 minutes post product use
Other outcomes:
Locations:
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: