Last updated: 11/03/2018 23:07:00
Consumer perception of an experimental mouthwash after a single use in dry mouth subjects
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study Evaluating the Consumer Perception of an Experimental Mouthwash Formulation After a Single Use
Trial description: The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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:
Number of Participants With Response to Post-Product use questionnaires 1 (PPUQ 1); Question No. 3-7
Timeframe: Within 2 minutes post product use
Number of Participants With Response to Post-Product use questionnaires 2 (PPUQ 2)
Timeframe: Within 30 ± 5 minutes post product use
Number of participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Timeframe: Within 5 minutes post product use
Interventions:
Other: Biotene mouthwash
Other: Bottled mineral water
Enrollment:
56
Observational study model:
Not applicable
Primary completion date:
2016-19-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Xerostomia
Product
GR157064, GR157075, GSK3737711, glycerol
Collaborators
Not applicable
Study date(s)
August 2016 to October 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 84 years
Accepts healthy volunteers
Yes
- 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
- 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
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02111
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2016-19-10
Actual study completion date
2016-19-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website