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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. Read our disclaimer for details. Identifier: NCT02690844
Recruitment Status : Withdrawn
First Posted : February 24, 2016
Last Update Posted : May 3, 2018
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
Drug Information available for: Clonazepam

Arm Intervention/treatment
Active Comparator: Clonazepam
Clonazepam (Klonopin®) treatment arm - 1 mg clonazepam (Klonopin® tablet) TID, dissolved in mouth for 3 minutes then expectorated
Drug: Clonazepam
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.

Primary Outcome Measures :
  1. Reduction of pain as judged by visual analogue scale (0 to 10) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Effect on quality of life issues using the Brief Pain Inventory [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Presence of burning mouth symptoms that cannot be attributed to any other organic cause.

Exclusion Criteria:

  • Laboratory examination will be performed and serum levels of iron, ferritin, folate, vitamin B12 and glucose will be measured. Normal levels required.
  • Use of anxiolytic or antidepressant for less than 6 months prior to study.
  • Resting salivary flow rates less than 0.1ml/min.
  • Presence of oral mucosal disease.

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Responsible Party: University of Alberta Identifier: NCT02690844     History of Changes
Other Study ID Numbers: 1182108
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Burning Mouth Syndrome
Pathologic Processes
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs