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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01343303
Eligibility Criteria:
Inclusion Criteria:
* Nonsmoker \>= 6 months prior to first dose
* body mass index (BMI) \<= 36 kg/m2
* Meet American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of knee by meeting at least 3 of the following: age \> 50, morning stiffness \< 30 minutes, crepitus on active motion, bony tenderness, bony enlargement, no palpable warmth of synovium
* Has Functional Class I-III osteoarthritis (OA) of knee with continuing OA-knee joint pain \>= 5 days/week x 3 months prior to screening, and has been taking a non-opioid analgesic for OA knee pain daily for \>=5 days prior to screening with benefit
* Otherwise healthy based on physical exam, medical history, vital signs, 12-lead electrocardiogram (ECG), can clinical laboratory tests
* Women must be postmenopausal or surgically sterile.
Exclusion Criteria:
* Oral temperature \>37.5 deg C at Screening or Day -1
* Failure of burn prevention measures quiz at Screening
* patients with occupations or hobbies in which they are routinely exposed to situations in which they could sustain burns
* orthopedic and/or prosthetic device on target knee joint
* Significant pain outside the target knee, including significant hip or back pain (bilateral knee OA is permitted)
* Unable to discontinue prior analgesic medications/non-steroidal antiinflammatory drugs (NSAIDS) other than paracetamol during the study
* Surgical intervention for any pain within 3 months prior to screening or has plans for surgical intervention while in the study
* History of prior diagnosis of inflammatory arthritis (including rheumatoid arthritis)
* Treatment with local corticosteroid injections or viscosupplementation in target joint, or use of oral or intramuscular corticosteroids, within 3 months prior to Screening
* History of active peptic ulceration, active dyspepsia, gastrointestinal bleeding, Crohn's disease, ulcerative colitis, chronic diarrhea esophageal, and gastric or duodenal ulcer within 3 months prior to screening or any other condition, which in the Investigator's opinion, precludes use of an NSAID.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01343303
Study Brief:
Protocol Section:
NCT01343303