An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee

Completed · Phase 2

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT00211549

Run by

IDEA AG

People needed

875

Starts

2005-06-01

Last updated by the study team

2009-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Montgomery, Alabama, United States
• Drug Research and Analysis Corporation — Montgomery, Alabama, United States
• Study site — Northport, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Encinitas, California, United States
• Study site — Fair Oaks, California, United States
• Study site — Garden Grove, California, United States
• Study site — Irvine, California, United States
• Study site — Paramount, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — San Diego, California, United States
• Study site — Spring Valley, California, United States
• Study site — Temecula, California, United States
• Study site — Vista, California, United States
• Study site — Northglenn, Colorado, United States
• Study site — Danbury, Connecticut, United States
• Study site — Clearwater, Florida, United States
• Study site — Coral Gables, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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