NCT00325858A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or HipChronic Pain
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NCT00347685A One-year, Open-label Study to Assess the Safety and Effectiveness of Extended Release Tramadol HCl in the Treatment of Chronic, Non-malignant Pain.Chronic Pain
A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip
The primary outcome is the change from baseline to Week 12 in the WOMAC OA Index pain and physical function subscale scores and the patient global assessment of disease activity.
Patient's pain intensity score since the previous visit,using a visual analog scale(VAS) where 0 mm = no pain and 100 mm = extreme pain.
The primary efficacy outcome is the change in arthritis pain intensity score
averages over the 12 weeks of the study.
The primary outcomes are analyses of adverse events (incidence, frequency,
severity, attribution, adverse events causing withdrawal from study)
Secondary Endpoints
The secondary outcomes include: the change from baseline in the daily arthritis pain intensity scores from patient diaries; WOMAC OA stiffness subscale score, OA pain intensity VAS for index and non-index joints, and Chronic Pain Sleep Inventory scale.
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 ...