Avenue Therapeutics announced that the first patient has been dosed in a pivotal Phase 3 clinical trial of IV tramadol for the management of moderate to moderately severe pain in patients following abdominoplasty surgery. The Phase 3, multicenter, randomized, double-blind, three-arm trial will evaluate the efficacy and safety of IV tramadol 50 mg versus placebo. Approximately 360 patients will be enrolled to IV tramadol 50 mg, placebo or morphine in a 3:3:2 ratio. The primary efficacy endpoint is the summed pain intensity difference over 24 hours compared to placebo.
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