Status:
COMPLETED
An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee
Lead Sponsor:
IDEA AG
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to identify the dose(s) of IDEA-033 that will provide a meaningful effect for treating osteoarthritis of the knee.
Detailed Description
The objective of this double-blind, placebo-controlled, randomized study is to evaluate the safety of and to identify the dose(s) of IDEA-033 that will provide a minimum clinically meaningful effect f...
Eligibility Criteria
Inclusion
- Osteoarthritis of both knees for minimum of six months
- Moderate pain in the most involved knee when not taking NSAIDs
- Must have used an oral NSAID on at least three days per week for last three months or 25 of 30 days before screening
- Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months
Exclusion
- Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria
- Intra-articular injections or arthroscopy of the most involved knee during three months before Screening visit
- Inflammation of the most involved knee that could be related to gout or pseudogout-induced synovitis or infection
- A large bulging effusion
- History of gout or pseudo-gout induced synovitis or infection of the more severe knee
- History of partial or total knee replacement in either knee
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
875 Patients enrolled
Trial Details
Trial ID
NCT00211549
Start Date
June 1 2005
Last Update
March 20 2009
Active Locations (100)
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1
Birmingham, Alabama, United States, 35209
2
Montgomery, Alabama, United States, 36101
3
Drug Research and Analysis Corporation
Montgomery, Alabama, United States, 36124
4
Northport, Alabama, United States, 35476