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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT02121002
Eligibility Criteria:
Inclusion Criteria:
* Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee.
* Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
* After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee
* If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study
* Able to tolerate rescue medication with paracetamol/acetaminophen.
Exclusion Criteria:
* Pregnant or lactating or planning to become pregnant during the study period.
* X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
* History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
* After discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.
* History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia.
* History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
* History of gastrointestinal bleeding or peptic ulcer disease.
* Use of warfarin or other anticoagulant therapy within 30 days of study randomization.
* Elevated transaminases at screening.
* Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization.
* Concomitant use of corticosteroids or use within 30 days of study randomization.
* Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
* Known allergy to aspirin or nonsteroidal anti-inflammatory drug
* Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study.
* Receipt of any drug as part of a research study within 30 days prior to screening.
* Previous participation in this study.
* Any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs).
* Recent history of major knee injury or surgery.
* Known history of positive HIV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT02121002
Study Brief:
Protocol Section:
NCT02121002