Results of the phase III clinical trial of tramadol (MDT3-005) will be added to the company’s new drug application (NDA), which is currently under FDA review.
The randomized, multi-centre study compared the safety and efficacy of Labopharm’s once-daily formulation of tramadol to placebo over a 12-week period. Enrollment in the trial consisted of patients diagnosed with moderate to severe pain associated with osteoarthritis of the knee. Approximately 1,000 patients were involved.
Participants were randomized to treatment with Labopharm’s once-daily tramadol or placebo and underwent double-blind titration to an optimal dose of either 200 or 300 mg. The optimal dose for each patient, which was maintained for a period of 12-weeks, was selected based on the effectiveness of pain relief and the tolerability of adverse events.
The primary endpoint of the study was to compare pain intensity at the beginning of the trial with its intensity at the end, as measured by a standardized rating scale. Results showed a highly significant reduction in pain was achieved over the 12 week period.