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NCT00001955 · ClinicalTrials.gov registry record · Phase 2
Study of Etanercept and Celecoxib to Treat Temporomandibular Disorders (Painful Joint Conditions)
A Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT00001955: Completed Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT00001955 is a Phase 2 study that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001955, a Phase 2 study, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study 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.
Interventions
- DRUG Celecoxib
- DRUG Etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 1999-12 |
| Est. Completion | 2004-02 |
| Phase | Phase 2 |
What the finished NCT00001955 record still lists
NCT00001955 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which Celecoxib is the first listed.
NCT00001955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001955 about?
NCT00001955 is a clinical study titled "Study of Etanercept and Celecoxib to Treat Temporomandibular Disorders (Painful Joint Conditions)". 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 Ad...
What is the current status of trial NCT00001955?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 1999-12. Estimated completion is 2004-02.
What interventions are being tested in trial NCT00001955?
The interventions under investigation include: Celecoxib (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT00001955?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001955's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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