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Labopharm: Phase 3 trials show tramadol safe for pain management
By E. Janene Geiss
Philadelphia, Sept. 8 - Labopharm Inc. said Friday that 12-week safety data from its three U.S. phase 3 clinical trials show that once-daily tramadol is well-positioned in the market.
The efficacy and safety of tramadol was evaluated over 12 weeks in three randomized, double-blind, placebo-controlled clinical trials in a total of 1,763 patients with osteoarthritis of the knee.
The most frequently reported adverse events that were possibly related to treatment with tramadol were nausea (16%), constipation (13%), dizziness/vertigo (11%), somnolence (7%) and vomiting (5%), according to a news release from the Laval, Quebec, specialty pharmaceutical company.
In comparison with the safety profiles of other tramadol formulations, traditional opioids and Nsaids, tramadol provides a safe alternative for the management of pain, the company said.
The company said it presented the data at the 17th annual Clinical Meeting of the American Academy of Pain Management in Orlando, Fla.
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