A Study of TRV130 for the Treatment of Pain After Abdominoplasty

A Phase 2, Randomized, Double-Blind, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain Following Abdominoplasty

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

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130 administered via patient controlled analgesia device (PCA) compared with placebo administered via PCA in patients with moderate to severe, acute postoperative pain following abdominoplasty.

Inclusion Criteria:

• >=18 and <=65 years of age.
• Plans to undergo an abdominoplasty procedure with no additional collateral procedures.
• Is able to understand and comply with the procedures and study requirements, and 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.