Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome
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|ClinicalTrials.gov Identifier: NCT02690844|
Recruitment Status : Withdrawn
First Posted : February 24, 2016
Last Update Posted : May 3, 2018
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)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
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 ]