Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome

NCT02690844 | Withdrawn Phase 4

• 1 other identifier: 1182108
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Burning Mouth Syndrome

Outcome Measures

Primary Outcomes (1)

• Reduction of pain as judged by visual analogue scale (0 to 10)

  4 weeks

Secondary Outcomes (1)

• Effect on quality of life issues using the Brief Pain Inventory

  4 weeks

Study Arms (3)

Clonazepam

ACTIVE COMPARATOR

Clonazepam (Klonopin®) treatment arm - 1 mg clonazepam (Klonopin® tablet) TID, dissolved in mouth for 3 minutes then expectorated

Drug: Clonazepam

Mucolox® alone

PLACEBO COMPARATOR

Mucolox® only - 5mL Mucolox® TID, swished around mouth for 3 minutes then expectorated

Drug: Mucolox® alone

Mucolox® and clonazepam

EXPERIMENTAL

Mucolox® and clonazepam - 1mg Clonazepam/5mL Mucolox® TID, swished around mouth for 3 minutes then expectorated.

Drug: Clonazepam mixed with Mucolox®

Interventions

Clonazepam mixed with Mucolox® DRUG

1mg clonazepam in 5mL Mucolox® will be used TID. Mixture will be swished around mouth for 3 minutes then spat out.

Mucolox® and clonazepam

Mucolox® alone DRUG

5mL Mucolox® TID. Mixture swished around mouth for 3 minutes then spat out.

Mucolox® alone

Clonazepam DRUG

1mg Clonazepam tablet will be used TID. Tablet dissolved in mouth, swished around and then expectorated.

Clonazepam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Clonazepam

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 24, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 3, 2018

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share