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Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms

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ClinicalTrials.gov Identifier: NCT02641912
Recruitment Status : Completed
First Posted : December 30, 2015
Results First Posted : January 27, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Xerostomia
Interventions: Other: Biotene mouthwash
Other: Mineral Water

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at one center in United States of America.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 104 participants were screened. Out of which 100 participants were randomized and stratified based on confirmed Sjögren’s syndrome status (Yes[Y]/No[N]).

Reporting Groups
  Description
Experimental Mouthwash During supervised product use: Participants rinsed with 15 milliliter (mL) of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
Mineral Water During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.

Participant Flow:   Overall Study
    Experimental Mouthwash   Mineral Water
STARTED   53   47 
COMPLETED   53   47 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Experimental Mouthwash During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
Mineral Water During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Total Total of all reporting groups

Baseline Measures
   Experimental Mouthwash   Mineral Water   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   47   100 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.66  (14.418)   51.57  (14.111)   51.09  (14.210) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      36  67.9%      28  59.6%      64  64.0% 
Male      17  32.1%      19  40.4%      36  36.0% 


  Outcome Measures

1.  Primary:   Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in Product Performance and Attributes Questionnaire 3 (PPAQ3) at 120 Minutes(Mins) Post Treatment on Day 8   [ Time Frame: 120 mins post treatment on Day 8 ]

2.  Secondary:   Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in Product Performance And Attributes Questionnaire 2 (PPAQ2) at 30 Mins Post Treatment on Day 8   [ Time Frame: 30 mins post treatment on Day 8 ]

3.  Secondary:   Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8   [ Time Frame: 60 and 240 mins post treatment on Day 8 ]

4.  Secondary:   Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8   [ Time Frame: 5 mins post treatment on Day 8 ]

5.  Secondary:   Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8   [ Time Frame: 30 mins post treatment on Day 8 ]

6.  Secondary:   Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8   [ Time Frame: 60 mins. post treatment on Day 8 ]

7.  Secondary:   Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8   [ Time Frame: 120 mins. post treatment on Day 8 ]

8.  Secondary:   Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8   [ Time Frame: 240 mins. post treatment on Day 8 ]

9.  Secondary:   Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8   [ Time Frame: prior to treatment on Day 8 ]

10.  Secondary:   Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1   [ Time Frame: 5 mins post treatment on Day 1 ]

11.  Secondary:   Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1   [ Time Frame: 30 mins post treatment on Day 1 ]

12.  Secondary:   Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1   [ Time Frame: 60 mins post treatment on Day 1 ]

13.  Secondary:   Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1   [ Time Frame: 120 mins post treatment on Day 1 ]

14.  Secondary:   Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1   [ Time Frame: 240 mins post treatment on Day 1 ]

15.  Secondary:   Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3   [ Time Frame: 5 mins post treatment on Day 3 ]

16.  Secondary:   Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3   [ Time Frame: 30 mins post treatment on Day 3 ]

17.  Secondary:   Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3   [ Time Frame: 60 mins. post treatment on Day 3 ]

18.  Secondary:   Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3   [ Time Frame: 120 mins post treatment on Day 3 ]

19.  Secondary:   Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3   [ Time Frame: 240 mins post treatment on Day 3 ]

20.  Secondary:   Mean Response to PPAQ4 Prior to Treatment on Day 3   [ Time Frame: Prior to treatment on Day 3 ]

21.  Secondary:   Mean Response to Subjective Assessment of Patient’s Quality of Life (SAoP QoL1) Prior to Treatment on Day 1   [ Time Frame: Prior to treatment on Day 1 ]

22.  Secondary:   Mean Response to SAoP QoL 2 Prior to Treatment on Day 8   [ Time Frame: prior to treatment on Day 8 ]

23.  Secondary:   Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1   [ Time Frame: Prior to treatment on Day 1 ]

24.  Secondary:   Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1   [ Time Frame: Prior to treatment on Day 1 ]

25.  Secondary:   Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1   [ Time Frame: Prior to treatment on Day 1 ]

26.  Secondary:   Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1   [ Time Frame: Prior to treatment on Day 1 ]

27.  Secondary:   Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8   [ Time Frame: Prior to treatment on Day 8 ]

28.  Secondary:   Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8   [ Time Frame: Prior to treatment on Day 8 ]

29.  Secondary:   Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8   [ Time Frame: Prior to treatment on Day 8 ]

30.  Secondary:   Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8   [ Time Frame: Prior to treatment on Day 8 ]

31.  Secondary:   Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8   [ Time Frame: Day 1, Day 3, Day 8 ]

32.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: up to 13 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02641912     History of Changes
Other Study ID Numbers: 204870
First Submitted: December 24, 2015
First Posted: December 30, 2015
Results First Submitted: November 30, 2016
Results First Posted: January 27, 2017
Last Update Posted: July 11, 2017