A Study Comparing the Effectiveness and Safety of Extended-release Tramadol Versus Placebo in the Treatment of Chronic Low Back Pain

• Status: Completed
• Trial end date: 2001-11-01
• Target enrollment: 0
• Participant gender: All

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 analgesic treatment. The study hypothesis is that tramadol ER is effective in the treatment of moderate to severe chronic low back pain.

• 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 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 Criteria:

• 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.