Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02690844|
Recruitment Status : Not yet recruiting
First Posted : February 24, 2016
Last Update Posted : February 24, 2016
What affect does the use of a mucoadhesive drug delivery system (Mucolox®) compounded with clonazepam have in the treatment of burning mouth syndrome?
There are no clinical trials reported in the literature that evaluate the use of a mucoadhesive vehicle to deliver clonazepam into the oral cavity and treat burning mouth syndrome. The use of a mucoadhesive may help to increase surface contact and elicit a greater reduction in symptoms.
|Condition or disease||Intervention/treatment||Phase|
|Burning Mouth Syndrome||Drug: Clonazepam mixed with Mucolox® Drug: Mucolox® alone Drug: Clonazepam||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||July 2018|
Active Comparator: Clonazepam
Clonazepam (Klonopin®) treatment arm - 1 mg clonazepam (Klonopin® tablet) TID, dissolved in mouth for 3 minutes then expectorated
1mg Clonazepam tablet will be used TID. Tablet dissolved in mouth, swished around and then expectorated.
Placebo Comparator: Mucolox® alone
Mucolox® only - 5mL Mucolox® TID, swished around mouth for 3 minutes then expectorated
Drug: Mucolox® alone
5mL Mucolox® TID. Mixture swished around mouth for 3 minutes then spat out.
Experimental: Mucolox® and clonazepam
Mucolox® and clonazepam - 1mg Clonazepam/5mL Mucolox® TID, swished around mouth for 3 minutes then expectorated.
Drug: Clonazepam mixed with Mucolox®
1mg clonazepam in 5mL Mucolox® will be used TID. Mixture will be swished around mouth for 3 minutes then spat out.
- Reduction of pain as judged by visual analogue scale (0 to 10) [ Time Frame: 4 weeks ]
- Effect on quality of life issues using the Brief Pain Inventory [ Time Frame: 4 weeks ]