A Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

Inclusion Criteria

• •Informed consent
• •Signed consent obtained at screening prior to any procedures being performed.
• •Gender
• •Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is post-menopausal or using an acceptable method of birth control (i.e., hormonal, transdermal, or implanted contraceptives, intra-uterine device, diaphragm, condom, abstinence, or surgical sterilization)
• •Age
• •At least 18 years of age
• •Diagnosis of OA
• •Clinical diagnosis of osteoarthritis of the hip and/or knee (signal joints) based on history and physical findings
• •Confirmation of OA
• •Radiographic evidence of OA of the knee or hip (e.g., joint space narrowing, K-L grades 1-4). \[Any X-ray finding or report of an X-ray finding at any time that is indicative of OA of the knee or hip confirms the diagnosis of OA.\]
• •Treatment of OA
• •Inadequate or unsatisfactory treatment with an NSAID for OA of the knee or hip with no previous use of an opioid for OA (i.e., need for "step up" to opioid treatment).
• •Flare of OA
• •Complaint of acute pain in the knee or hip (i.e., "flare" of osteoarthritis of the knee or hip)
• •Duration of Acute Pain
• •Pain in the signal joint(s) with onset ≤ 14 days
• •Pain Severity
• •Baseline PIS score must be ≥ moderate
• •Alcohol Intake
• •Willing to limit alcohol intake to ≤ 2 drinks per day during the study (i.e., from Screening Visit 1 through Follow-Up Visit 3)
• •Diary Completion
• •Be willing and able to record effectiveness, tolerability, and drug utilization information in the In-Clinic and Outpatient Diaries.