Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT00265304
Eligibility Criteria:
Inclusion Criteria:
* Patients who completed Study 17-007 or discontinued from Study 17-007 due to lack of efficacy
* Patients who did not complete or discontinue from Study 17-007 must have osteoarthritis of both knees for a minimum of six months
* Have moderate pain in the most involved knee when not taking non-steroidal anti-inflammatory drugs (NSAIDs)
* Must have used an oral NSAID on at least three days per week for the last three months, or 25 of the 30 days before screening
* Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months
Exclusion Criteria:
* Any patient currently receiving physical therapy to either knee or having a history of allergy, hypersensitivity or contraindication to ketoprofen, naproxen, or acetaminophen, an NSAID idiosyncrasy, or any other medical condition that would compromise the ability of the subject to complete the required assessments and visits
* For patients who did not participate in Study 17-007: having Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria
* Received intra-articular injections or arthroscopy of the most involved knee during three months before screening visit
* Have a large bulging effusion, or have inflammation of the most involved knee that could be related to gout, pseudogout-induced synovitis, or infection
* Have a history of partial or total knee replacement in either knee, or have a history of gout, pseudo-gout induced synovitis, or infection of the more severe knee
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00265304
Study Brief:
Protocol Section:
NCT00265304