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Adverse Drug Reactions



Labopharm reports results for Phase III study on twice-daily tramadol-acetaminophen formulation



April 17th, 2009

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) announced the results of its recently completed North American Phase III clinical trial for its twice-daily formulation of tramadol and acetaminophen (study 06CCL3-001).

Study 06CCL3-001 was a multi-centre, randomized, double-blind, parallel-arm study that compared the efficacy and safety of Labopharm's twice-daily tramadol-acetaminophen formulation to placebo in the treatment of moderate to severe acute low back pain. A total of 277 patients were included in the study. Thirteen percent (13%) of patients in the active treatment group discontinued early (12% due to adverse events) and 5% of patients in the placebo group...


Source: Health Business Week (2009-04-17)

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