| 2018-12-19 08:20:48|
ATXI 08:20 12/19 12/19/18
Avenue Therapeutics doses first patient in Phase 3 trial of IV tramadol
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.