Study of Etanercept and Celecoxib to Treat Temporomandibular Disorders (Painful Joint Conditions)

Phase 2

Completed

• Conditions: Temporomandibular Joint Disorder

• Registration Number: NCT00001955
• Lead Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Brief Summary

This 2-part study will evaluate the effectiveness and side effects of two anti-inflammatory drugs for relieving pain and improving jaw function in patients with temporomandibular disorder (TMD). Part 1 will evaluate celecoxib (Celebrex); Part 2 will evaluate etanercept (Enbrel). The Food and Drug Administration has approved both of these drugs for treating certain forms of arthritis.

Patients between the ages of 18 and 65 years with painful jaw joint conditions may be eligible for this study. Candidates will complete several written questionnaires about their jaw condition and will undergo a medical history, complete TMD evaluation, blood and urine tests, and imaging studies of the temporomandibular joint, such as X-rays and magnetic resonance imaging. Patients will rate the quality and intensity of their pain before beginning treatment. At certain periods during the study, they will also keep a pain diary, twice a day recording the intensity and magnitude of their pain.

Part 1 - Celecoxib: Patients will be randomly assigned to receive either 1) celecoxib twice a day by mouth; 2) naproxen (a non-steroidal anti-inflammatory drug) twice a day by mouth; or 3) a placebo (inactive pill) twice a day by mouth.

Part 2 - Etanercept: Patients will be randomly assigned to receive either 1) etanercept injected under the skin or 2) saline (an inactive placebo) injected under the skin. Patients in this group will also undergo two aspirations of fluid from the jaw joint - once before treatment begins and again 6 weeks later. For this procedure, the joint is numbed with an anesthetic and then a needle is inserted into the jaw space to withdraw fluid, which will be analyzed for inflammatory processes in the joint.

All patients will have a final evaluation 6 weeks after beginning treatment, including a TMD physical examination, laboratory and X-ray tests as required. The pain diary and questionnaires will be collected at this visit.

Detailed Description

The proposed clinical trial will consist of two parallel studies. In the first part of the study, we will evaluate the analgesia and adverse effects of celecoxib, a COX-2 inhibitor in comparison to naproxen and placebo of patients with temporomandibular disorders (TMD). Celecoxib, is in oral anti-inflammatory and analgesic agent that acts by selectively inhibiting cyclooxygenase 2 (COX-2) and is not expected to cause the typical gastrointestinal, and platelet-related side effects associated with inhibition of the COX-1 enzyme. Decrease in pain, dysfunction and improvement in quality of life will be assessed at base line and after 6-week follow-up. Successful demonstration of an enhanced therapeutic effect or reduced toxicity may provide a basis for clinical use of selective COX-2 inhibitors in patients with painful TMD.

In a second group of carefully selected patients, we will evaluate the short-term effect etanercept (Enbrel) in comparison to placebo in patients who had pain and tenderness to palpation in the temporomandibular joint (TMJ osteoarthritis) of at least three month duration and who had not responded to conservative treatment. Etanercept is a biologic modifier that binds specifically to tumor necrosis factor alpha (TNF alpha). The mechanism of action of etanercept is competitive inhibition of TNF binding to cell-surface TNF receptors (TNFR), preventing TNF-mediated cellular responses by rendering TNF biologically inactive. Subjects will be randomly assigned to either etanercept or placebo administration. At baseline and at 6-week follow up individual outcomes will be assessed such as pain, mandibular range of motion along with the analysis of the sample synovial fluid level of TNF alpha. By studying the joint fluid levels of TNF alpha, we will learn more about the development of the local inflammatory process in the joint, which will help in predicting the prognosis for patients with these TM joint disorders. Positive findings will also provide clinical implications of etanercept in patients with painful TMJ osteoarthritis.

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2000-01-18
• Study First Submitted QC: 2000-01-18
• Study First Posted: 2000-01-19
• Status Verified: 2004-02
• Study Completion: 2004-02
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Institute of Dental And Craniofacial Research (NIDCR); 🇺🇸 Bethesda, Maryland, United States