Status:
COMPLETED
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
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Chronic Pain
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00325858
Start Date
January 1 2002
End Date
December 1 2003
Last Update
August 27 2012
Active Locations (1)
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1
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635