Status:
COMPLETED
A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.
Eligibility Criteria
Inclusion
- Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee
- Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III
- Patients required to demonstrate a "flare" of the signs and symptoms of OA following withdrawal of NSAID treatment
- Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA.
Exclusion
- No history of concurrent arthritic disease
- uncontrolled hypertension or an active cardiac condition
- No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.
Key Trial Info
Start Date :
February 5 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2003
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT00269191
Start Date
February 5 2003
End Date
November 21 2003
Last Update
August 15 2024
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