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

Launched by BAUSCH HEALTH AMERICAS, INC. · May 11, 2006

Keywords

ClinConnect Summary

Immediate release (IR) tramadol has demonstrated efficacy in several pain conditions including: obstetrical, gynecological, orthopedic, abdominal, and oral surgery. The short elimination half-life of tramadol IR necessitates every 4-6 hour dosing to maintain optimal levels of analgesia in chronic pain. The study medication in this study is a once-daily, extended-release tramadol formulation. This is a 12-week multi-center, double-blind, randomized, dose-ranging, parallel-group, fixed-dose, placebo-controlled study. Patients with OA Functional Class I-III of the knee or hip (index joint) are...

Gender

ALL

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