Status:
COMPLETED
Evaluation of a TNF-Alpha Modulator for Clinical and Molecular Indicators of Analgesic Effect
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Pain
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
This study will evaluate the role of thalidomide, a tumor necrosis factor (TNF)-alpha modulator, on severe inflammation and relief of pain following extraction of wisdom teeth. TNFs are substances tha...
Detailed Description
The proposed investigation is a randomized, double-blind, placebo and positive-controlled clinical study to evaluate the role of the cytokine tumor necrosis factor alpha (TNF-alpha) modulator, thalido...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- male patients referred for extraction of third molars willing to undergo surgical extraction of all indicated third molars
- a minimum of one partial-bony impacted third molar, with a total difficulty score total of not less than 8
- between the ages of 16 to 35 years (based upon eruption patterns and age-related complications associated with surgical extraction of third molars)
- in good general health- ASA status 1 or 2 (healthy subjects based upon criteria for safe outpatient conscious sedation)
- willing to undergo observation period for six hours postoperatively
- EXCLUSION CRITERIA:
- females
- current mental disorder or substance abuse
- allergy to aspirin, NSAIDs, or sulfonamide
- history of peptic ulcers and GI bleeding
- concurrent use of agents which may potentiate the sedative effect of study drugs, alcohol, opioids, benzodiazapines
- chronic use of medications confounding assessment of the inflammatory response or analgesia, antihistamines, NSAIDs, steroids, antidepressants
- presence of chronic debilitating disease (such as diabetes, rheumatoid arthritis, liver disease, etc.)
- presence of symptomatic tooth suggesting infection or inflammation
- excessive surgical difficulty encountered during the surgical procedure, resulting in a difficulty score of 5 for any tooth
- patients with acute narrow angle glaucoma, and open angle glaucoma who are not receiving therapy
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00121563
Start Date
July 1 2005
End Date
February 1 2006
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Nursing Research (NINR)
Bethesda, Maryland, United States, 20892