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:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT00792727
Eligibility Criteria:
Inclusion Criteria:
* man or woman ≥45 years of age.
* clinical diagnosis of unilateral or bilateral OA of the knee
* taking an NSAID or acetaminophen on a regular basis and has a history of knee pain amelioration with NSAID or acetaminophen use.
* mild to moderate OA of the knee at the screening visit
* subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a NSAID or acetaminophen.
* subject understands that treatment will be administered on an inpatient basis.
* subject is capable of understanding and complying with the protocol and has signed the informed consent document.
Exclusion Criteria:
* subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
* subject has symptoms that are attributable to primary inflammatory diseases of the joint
* subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
* subject has arthropathies that occur in conjunction with systemic diseases
* subject has a chronic pain condition
* subject is grossly obese
* subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.
* subject has a history of osteotomies.
* subject is not willing to discontinue the use of NSAIDs, acetaminophen or other prohibited treatments
* subject used opioids for OA pain within 1 month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT00792727
Study Brief:
Protocol Section:
NCT00792727