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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Pain

In brief

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.

Key facts

Study ID

NCT02815709

Run by

Trevena Inc.

People needed

418

Starts

2016-05-01

Expected to finish

2017-01-01

Last updated by the study team

2020-09-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Pasadena, California, United States
• Research Site — Pasadena, Maryland, United States
• Research Site — Austin, Texas, United States
• Research Site — San Antonio, Texas, United States
• Resarch Site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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