Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.

Inclusion Criteria:

• Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
• Experiences a pain intensity rating of moderate to severe acute pain.
• 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.