Status:
COMPLETED
A Study Comparing the Effectiveness and Safety of Extended-release Tramadol Versus Placebo in the Treatment of Chronic Low Back Pain
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Chronic Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the analgesic efficacy of oral, once-daily tramadol ER 300 mg and 200 mg to placebo in patients with moderate to severe chronic low back pain requiring daily an...
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 a history of chronic low back pain \>= 6 months requiring treatment with NSAIDs, acetaminophen, opioid analgesics, COX-2 selective inhibitors, and/or muscle relaxants for at least 60 of the 90 days preceeding the screening visit; in good health as determined by the investigator on the basis of medical history, physical exam and screening labs; patient's low back pain intensity measures \>= 40 mm on a visual analog scale (VAS) at the start of the run-in peroid after the 2-7 day washout; patients who are able to discontinue treatment with NSAIDs, COX-2 selective inhibitors, tramadol, muscle relaxants, opioids, and/or other analgesics during the 2-7 day washout period and all other analgesics throughout the entire study.
Exclusion
- Patients with a diagnosis of a complex regional pain syndrome, significant inflammatory pain, or clinically significant active fibromyalgia; patients with a history of lumbar surgery or chemonucleolysis; patients undergoing transcutaneous electrical nerve stimulation (TENS) or spinal manipulation for low back pain; patients with an uncontrolled medical condition or a clinically significant condition that would, in the investigator's opinion, preclude study participation; patients using analgesics or other agents during washout that could confound the analgesic response.
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
November 1 2001
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00347724
Start Date
November 1 2000
End Date
November 1 2001
Last Update
June 21 2012
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