Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001955
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Brief Title:
Study of Etanercept and Celecoxib to Treat Temporomandibular Disorders Painful Joint Conditions
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Role of Cytokines as Inflammatory Mediators in Painful Temporomandibular Joints
Status:
COMPLETED
Status Verified Date:
2004-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-D-0037 | None | None | None |