Duloxetine for Treatment of Painful Temporomandibular Joint Disorder
This study has been completed.
Sponsor:
University of Maryland
Information provided by (Responsible Party):
Sharon Gordon, University of Maryland
ClinicalTrials.gov Identifier:
NCT00981149
First received: September 18, 2009
Last updated: June 25, 2012
Last verified: June 2012
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Purpose
Temporomandibular joint disorders (TMJD) are a family of musculoskeletal disorders that represent the most common chronic orofacial pain condition. TMJD is associated with persistent pain in the region of the temporomandibular joint and muscles of the head and neck. The purpose of this study is to test duloxetine (Cymbalta) as a potential treatment for chronic facial pain. Duloxetine is FDA approved as an antidepressant and for the chronic pain conditions of fibromyalgia and diabetic neuropathy. Chronic facial pain may be linked to Temporomandibular Joint Disorder (TMJD) which currently has no standard treatment.
| Condition | Intervention |
|---|---|
|
Temporomandibular Joint Disorders |
Drug: duloxetine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Duloxetine for Treatment of Painful Temporomandibular Joint Disorder |
Resource links provided by NLM:
Further study details as provided by University of Maryland:
Primary Outcome Measures:
- The primary outcome measure of spontaneous craniofacial pain will be assessed using the pain visual analogue scale (VAS) to derive the primary outcome variable of Pain Intensity Difference using BL pain as a covariate. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain with jaw function and upon muscle and joint palpation as measured by VAS as secondary outcome measures. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | May 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: duloxetine study drug
Drug (including placebo)
|
Drug: duloxetine
Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period
Other Name: Cymbalta
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients with chronic TMJD pain of two weeks duration
- Age 18 and older
- Confirmed craniofacial pain of nonodontogenic origin by the Research Diagnostic Criteria for temporomandibular disorders (TMD-RDC)
- Concomitant medications are permitted, except those which may convey analgesia
- Females who are neither pregnant, as verified by a urine-based pregnancy test, nor breast-feeding
- Female subjects of childbearing potential and those who are post-menopausal for less than 2 years must be using/willing to use a medically approved method of contraception (i.e., oral, transdermal or implanted contraceptive devices, intrauterine device, diaphragm, condom, abstinence, or surgical sterility during the course of the study
- Able to read and comprehend the rating scales, study instructions, and the consent form
- Pain score of 4 or greater on the baseline VAS (0-10)
Exclusion Criteria:
- Undergone any type of TMJ surgery or had TMJ growth disturbances, neoplasm, or injury to the TMJ area within the past six months
- Taking analgesic or anti-inflammatory drugs, steroids, antidepressants, antiepileptics, or opioid medications that may confound the assessment of analgesia
- Subjects with primary psychiatric diagnosis of major depression, suicidal ideation, or history of suicide attempt as assessed by medical history and the Mini International Neuropsychiatric Interview (MINI) are not eligible. Subjects with a score above average or higher in comparison with normative scores on the Beck Depression Inventory (BDI) will be allowed to participate
Exclusions based on the effects of duloxetine:
- Known hypersensitivity to duloxetine or its inactive ingredients
- Subjects with: renal impairment or end stage renal disease; urinary retention or hesitation, delayed gastric emptying; substantial alcohol use or evidence of chronic liver disease, hepatic insufficiency and hepatotoxicity; bleeding disorders, orthostatic hypotension, uncontrolled high blood pressure; recent history of myocardial infarction or unstable coronary artery disease; seizure disorder, history of bipolar disorder or mania, general anxiety disorder (GAD); hyponatremia; uncontrolled narrow-angle glaucoma.
- Treatment with an monoamine oxidase inhibitor (MAOI) within 30 days of randomization, or potential need to use an MAOI during the study or within 5 days of discontinuation of the drug
- Concomitant use of medications such as: NSAIDs, warfarin, aspirin or other drugs that affect coagulation; Thioridazine and inhibitors of CYP1A2 which affect metabolism of duloxetine; serotonergic drugs like triptans and MAOIs which increase the risk of Serotonin Syndrome; drugs that affect gastric acidity
- Contraindications to acetaminophen use
- Ever been treated with duloxetine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981149
Locations
| United States, Maryland | |
| University of Maryland Dental School | |
| Baltimore, Maryland, United States, 21201 | |
Sponsors and Collaborators
University of Maryland
Investigators
| Principal Investigator: | Sharon M Gordon, DDS, MPH, PhD | University of Maryland Dental School |
More Information
No publications provided
| Responsible Party: | Sharon Gordon, Associate Professor, University of Maryland |
| ClinicalTrials.gov Identifier: | NCT00981149 History of Changes |
| Other Study ID Numbers: | HP-00040504 |
| Study First Received: | September 18, 2009 |
| Last Updated: | June 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Joint Diseases Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Musculoskeletal Diseases Craniomandibular Disorders Mandibular Diseases Jaw Diseases Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013