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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Clinical Study Evaluating the Consumer Perception of an Experimental Mouthwash Formulation After a Single Use

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

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Response to Post-Product use questionnaires 1 (PPUQ); Question No.1 [ Time Frame: Within 2 minutes post product use ]

Participants will answer the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? "This product is gentle": Disagree strongly, Disagree, Neither agree nor disagree, Agree, or Agree strongly.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response to Post-Product use questionnaires 1 Question No. 3-7 [ Time Frame: Within 2 minutes post product use ]
    Which of the following statements best describes how much you liked the product overall? Liked it extremely, Liked it very much, Liked it somewhat, Liked it slightly, Did not like it that much, Did not like it at all. Q 4: Which of the following statements best describes how much you liked the OVERALL FLAVOR of the rinse? Liked it extremely, Liked it very much, Liked it somewhat, Liked it slightly, Did not like it that much, Did not like it at all. Q 5: How you would rate the FLAVOR INTENSITY of the Oral Rinse? Strongest flavour imaginable, Very strong, Strong, Moderate, Weak, Barely detectable, No flavour at all. Q 6: Did you experience any of the following sensations in your mouth and how strong was the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who select "None"for a particular sensation would not complete Q 7 for that sensation: When did you experience the sensations in your mouth? Initially, During use, or After use.
  • Adverse events (AE) [ Time Frame: Up to 12 days ]
    An AE is any untoward medical occurrence in a participants or clinical investigation participant, temporally associated with the use of an investigational or washout product, whether or not considered related to the investigational or washout product.
  • Response to Product Performance Attribute Questionnaire (PPAQ) [ Time Frame: Within 5 minutes post product use ]
    Participants will rate on a scale of 1 to 5 (1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) each of following as they apply: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect.
  • Response to Post-Product use questionnaires 2 [ Time Frame: Within 30 ± 5 minutes post product use ]
    Participants will answer the following questions; Q1: Are you experiencing any of the following sensations in your mouth and how strong is the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out . Q2: Would you continue use of the product? (Yes or No)


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: August 30, 2016
Date Started: August 2016
Date Completion:
Last Updated: December 23, 2016
Last Verified: December 2016