Trial record 70 of 171 for:    TMD/TMJ

Duloxetine for Treatment of Painful Temporomandibular Joint Disorder

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: NCT00981149
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : November 1, 2017
Last Update Posted : April 13, 2018
Information provided by (Responsible Party):
Sharon Gordon, University of Maryland

Brief Summary:
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 or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Drug: duloxetine Drug: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Duloxetine for Treatment of Painful Temporomandibular Joint Disorder
Study Start Date : May 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: duloxetine study drug
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

Placebo Comparator: Placebo
Drug: Placebo
Placebo match duloxetine for 6 week period.

Primary Outcome Measures :
  1. Spontaneous Pain as Measured by Visual Analog Scale at Baseline and at End of 6 Weeks. [ Time Frame: 1, 3, 6 weeks ]
    Measurements from zero to 100 with 100 being the worst pain by Visual Analog Scale (VAS).

Secondary Outcome Measures :
  1. Evoked Pain Via Algometry . [ Time Frame: 6 weeks ]
    Assessment of evoked pain using digital palpation examination at 18 predefined bodily sites.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00981149

United States, Maryland
University of Maryland Dental School
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Principal Investigator: Sharon M Gordon, DDS MPH, PhD University of Maryland Dental School

Responsible Party: Sharon Gordon, Associate Professor, University of Maryland Identifier: NCT00981149     History of Changes
Other Study ID Numbers: HP-00040504
First Posted: September 22, 2009    Key Record Dates
Results First Posted: November 1, 2017
Last Update Posted: April 13, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Pathologic Processes
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents