Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects

Completed · Not applicable

Conditions studied: Xerostomia

In brief

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

Key facts

Study ID

NCT03005041

Run by

GlaxoSmithKline

People needed

56

Starts

2016-08-31

Expected to finish

2016-10-19

Last updated by the study team

2018-07-19

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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 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

Where it is running

• GSK Investigational Site — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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