In its first phase 3 clinical trial, intravenous (IV) tramadol has met its primary endpoint for relieving postoperative pain. In other news, the U.S. Food and Drug Administration (FDA) did not approve a new drug application for IV meloxicam.
Intravenous Tramadol in Phase 3 Clinical Trials
In its first phase 3 clinical trial, intravenous (IV) tramadol has met its primary endpoint, achieving a statistically significant improvement in the Sum of Pain Intensity Difference over 48 hours.1 This trial was a multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of IV tramadol for postoperative pain.
These primary endpoint results were compared with placebo in patients with moderate to severe postoperative pain post-bunionectomy (N=409). Secondary trial endpoints were also met. These include SPID24, total rescue medicine consumption and Patient Global Assessment (P<0.01; for all three compared with placebo-treated patients). Additionally, IV tramadol showed a clear dose response.
During the study, patients were randomized to a postoperative regimen of 50 mg IV tramadol, 25 mg IV tramadol or placebo given over 15 minutes at Hours 0, 2 and 4. Dosing was also given once every four hours thereafter for up to 13 doses in a 1:1:1 ratio. Statistically significant improvement in pain reduction occurred as early as 30 minutes after dosing, which was the first assessment time.| | | Next → | Single Page