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

May 21, 2018 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Product 1
Participants will rinse their mouth with 15 mL of the product swishing for 30 seconds.
Other: Biotene mouthwash
Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds.
Other: Test Product 2
Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds. Participants then spit out the water.
Other: Bottled mineral water
Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Time Frame: Within 2 minutes post product use
Participants answered 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. There was no formal statistical hypothesis to be tested for this outcome..
Within 2 minutes post product use

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Time Frame: Within 2 minutes post product use
Participants answered the following questions, Q3: Which of following statements best describes how much you liked product overall? liked it-extremely, very much, somewhat, 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 overall flavor of rinse? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 5: How you would rate flavor intensity of oral rinse? strongest flavor imaginable, very strong, strong, moderate, weak, barely detectable, no flavor at all. Q 6: Did you experience any of following sensations in your mouth & how strong was sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who selected "None" for a particular sensation, did not complete Q 7 for that sensation: When did you experience sensations in your mouth? initially, during use, or after use.
Within 2 minutes post product use
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Time Frame: Within 30 ± 5 minutes post product use
Participants answered the following question; 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)
Within 30 ± 5 minutes post product use
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Time Frame: Within 5 minutes post product use
Participants rated the following criteria on a scale of 1 to 5(1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) as follows: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect.
Within 5 minutes post product use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 19, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 19, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Xerostomia

Clinical Trials on Biotene mouthwash

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings