Duloxetine for Treatment of Painful Temporomandibular Joint Disorder

NCT00981149 | Completed Results DMC

• 1 other identifier: HP-00040504
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (1)

• Spontaneous Pain as Measured by Visual Analog Scale at Baseline and at End of 6 Weeks.

  Measurements from zero to 100 with 100 being the worst pain by Visual Analog Scale (VAS).

  1, 3, 6 weeks

Secondary Outcomes (1)

• Evoked Pain Via Algometry .

  6 weeks

Study Arms (2)

duloxetine study drug

EXPERIMENTAL

Drug

Drug: duloxetine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

duloxetine DRUG

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

Also known as: Cymbalta

duloxetine study drug

Placebo DRUG

Placebo match duloxetine for 6 week period.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Dental School

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Sharon Gordon, DDS
• Organization: ECU SODM

gordons@ecu.edu

2527377125

Study Officials

• Sharon M Gordon, DDS MPH, PhD

  University of Maryland Dental School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 22, 2009
• Study Start: May 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 25, 2021
• Results First Posted: November 1, 2017

Record last verified: 2021-05

Locations

US (1)