Three phase 3 clinical trials of tramadolshowed that the safety and efficacyof the once-daily formulation offers asafe alternative for the management ofpain. The drug's manufacturer, Labopharm,presented data at the 17thAnnual Clinical Meeting of the AmericanAcademy of Pain Management inSeptember 2006. The 12-week, randomized,double-blind, placebo-controlled trialsincluded 1763 patients withosteoarthritis of the knee. Doses rangingfrom 100 to 300 mg were randomized to1095 patients, while 668 patientsreceived placebo. The most frequentadverse events reported were nausea,constipation, dizziness/vertigo, somnolence,and vomiting. Adverse eventsappeared in at least 5% in all doses, but90% of these events were reported to bemild or moderate. When compared withother formulations of tramadol, traditionalopioids, and nonsteroidal anti-inflammatorydrugs, the once-daily tramadoloffered a safe alternative for pain management.
Ms. Farley is a freelance medicalwriter based in Wakefield, RI.