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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT00733902
Eligibility Criteria:
Inclusion Criteria:
* Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2.
* Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.
* Pain level and function levels as required by the protocol at Screening and Baseline.
* Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.
* Must agree to the contraceptive requirements of the protocol if applicable.
* Must agree to the treatment plan, scheduled visits, and procedures of the protocol.
Exclusion Criteria:
* Pregnancy or intent to become pregnant during the study
* BMI greater than 39
* other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00733902
Study Brief:
Protocol Section:
NCT00733902