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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT00325858
Eligibility Criteria:
Inclusion Criteria:
* Patients with American College of Rheumatology (ACR) Functional Class I-III OA of the knee or hip
* Patients with involvement of at least one knee or hip joint that warrants treatment with COX-2 inhibitors, NSAIDS, acetaminophen, or opioid analgesics for at least 75 of the 90 days preceding the screening visit
* Patients with a pain intensity score in index joint \>=40 mm on the visual analog scale (VAS) at the baseline visit
* Patients who are able to discontinue acetaminophen, NSAIDS, COX-2 selective inhibitors, and other analgesics during the washout period and throughout the study
* Patients who are able to understand the study procedures and complete pain scales
Exclusion Criteria:
* Patients with a medical condition, other than OA, uncontrolled with treatment or any clinically significant condition that, in the investigator's opinion, precludes study participation or interferes with the assessment of chronic pain and other OA symptoms
* Patients with a diagnosis of inflammatory arthritis, gout, pseudo-gout or Paget's disease, that, in the investigator's opinion, interferes with the assessment of pain and other symptoms of OA
* Patients with a diagnosis of chronic pain syndrome
* Patients with an ACR or a clinical diagnosis of fibromyalgia
* Patients with a clinically significant form of joint disease or prior joint replacement surgery at the index joint
* Patients with an anticipated need for surgery or other invasive procedure in the index joint
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT00325858
Study Brief:
Protocol Section:
NCT00325858