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news.Labopharm has started enrolling patients in the Phase III clinical trial for its twice-daily, tramadol-acetaminophen combination product for treatment of acute low back pain.
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The trial (study 06CCL3-001) is a multi-centre, randomized, double-blind, parallel-arm study that will compare the efficacy and safety of company’s twice-daily tramadol-acetaminophen combination product. The study, which is being conducted at more than 20 centers in the US and Canada, has a treatment period of approximately one week and is expected to include more than 250 patients.
James Howard-Tripp, president and CEO of Labopharm, said: “Our formulation has the potential to be the first twice-daily tramadol-acetaminophen product, as well as to compete in the broader acute pain prescription drug market globally. Accordingly, it would be an excellent complement to our once-daily tramadol product for the treatment of persistent pain.”