Duloxetine for Treatment of Painful Temporomandibular Joint Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sharon Gordon, University of Maryland
ClinicalTrials.gov Identifier:
NCT00981149
First received: September 18, 2009
Last updated: July 9, 2013
Last verified: July 2013
  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 ]

Enrollment: 24
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 9, 2013
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 July 24, 2014