A Study of TRV130 for the Treatment of Pain After Bunionectomy

A Phase 2, Multicenter, Randomized, Double-blind, Multiple-dose, Adaptive, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain After Bunionectomy

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.

Inclusion Criteria:

• Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
• Experiences a pain intensity rating of ≥ 4 on an 11 point NRS
• Able to provide written informed consent before any study procedure.

Exclusion Criteria:

• ASA Physical Status Classification System classification of P3 or worse
• Has surgical or post-surgical complications.
• Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Has previously participated in another TRV130 clinical study.