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Trial record 5 of 19 for:    "Burning Mouth Syndrome"

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Recruitment Status : Withdrawn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
Sponsor:
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

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 ]


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

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.

Responsible Party: University of Alberta
ClinicalTrials.gov 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:
Burning Mouth Syndrome
Syndrome
Burns
Disease
Pathologic Processes
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases
Clonazepam
Anticonvulsants
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs