A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Acetaminophen and Tramadol Combination BID Versus Placebo for the Treatment of Acute Low Back Pain

Phase 3 Completed 277 enrolled Labopharm Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and safety of Acetram Contramid® BID versus placebo for the treatment of acute low back pain in patients between 18 and 80 yrs of age.

Timeline

Start: 2008-03
Primary completion: 2009-01
Completion: 2009-02

Publications

Lasko B, Levitt RJ, Rainsford KD, Bouchard S, Rozova A, Robertson S. Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized, placebo-controlled study in patients with acute low back pain. Curr Med Res Opin. 2012 May;28(5):847-57. doi: 10.1185/03007995.2012.681035. Epub 2012 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	650 mg	Oral
Comparator	Tramadol	Other / unclassified	75 mg	Oral

Indications

No indication recorded.