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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00927004
Eligibility Criteria:
Inclusion Criteria:
* unilateral diagnosis of Knee OA \> 6 months
* knee pain \> 4/10 on WOMAC pain subscale
* if pain in contralateral knee, no greater than "mild"
* no other significant joint involvement
* ARA functional Class I, II or III
* no arthroscopy or injections into index knee in last 6 months
Exclusion Criteria:
* history of systemic inflammatory or chronic pain disorders (especially fibromyalgia)
* neurological deficit
* recent (\< 6 months) lower limb surgery
* allergic reaction to NSAIDs or aspirin
* skin allergies, dermatitis
* contraindications to Cox-2 inhibitors:
* congestive heart failure (NYHA II-IV)
* unstable hypertension
* ischaemic heart disease
* peripheral artery disease
* cerebrovascular disease including CABG or angioplasty within 1 year
* severe hepatic dysfunction
* active GI bleeding or peptic ulceration
* reduced creatinine clearance \< 30 mL/min
* current use of high dose (\> 325 mg daily) aspirin
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00927004
Study Brief:
Protocol Section:
NCT00927004