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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01890902
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of OA of the knee according to the ACR criteria.
* Kellgren-Lawrence grade 2-3 disease
* Be willing to stop taking all analgesics including NSAIDs and opioids for the duration of the study, with exception of study-specified rescue medication.
Exclusion Criteria:
* Total knee replacement surgery tentatively scheduled within next 6 months.
* Palpable knee effusion.
* Significant pain outside the target knee, including significant hip, back, or contralateral knee pain.
* Any type of orthopedic and/or prosthetic device or any skin abnormalities on the target knee that would prevent evaluations of local tolerability.
* History of asthma, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis), or fibromyalgia.
* History of gastrointestinal bleeding or peptic ulcer disease within the past 3 years.
* Have a positive urine drug test for illegal drug substances, non-prescribed controlled substances, or alcohol at screening.
* Acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT01890902
Study Brief:
Protocol Section:
NCT01890902