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

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness of multiple doses of once daily tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe pain due to OA. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of patients with moderate to severe pain due to OA.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Tramadol

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