Status:
COMPLETED
A Study Comparing the Effectiveness and Safety of Extended Release Tramadol Versus Placebo for the Treatment of Osteoarthritis (OA) of the Knee
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the analgesic effectiveness and safety of tramadol HCl ER to placebo in patients with moderate to severe pain due to osteoarthritis (OA). The study hypothesis i...
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; involvement of at least one knee joint that warrants treatment with NSAIDs, acetaminophen, or opioid analgesics for at least 75 of the 90 days preceding the screening visit; patients with radiographic evidence of osteoarthritis within the last 6 months; patients with a pain intensity in index joint \> = 40 mm on the visual analog scale (VAS) at the baseline visit; patients who are able to discontinue NSAIDs, COX-2 selective inhibitors, and other analgesics during the washout period and throughout double-blind study.
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 :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
July 1 2001
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00348010
Start Date
November 1 2000
End Date
July 1 2001
Last Update
June 21 2012
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