A Study of TRV130 for the Treatment of Pain After Bunionectomy

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Pain

In brief

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

Key facts

Study ID

NCT02100748

Run by

Trevena Inc.

People needed

333

Starts

2014-04-01

Expected to finish

2014-10-01

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not 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 ≥ 4 on an 11 point NRS
• 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

• Premier Research — Phoenix, Arizona, United States
• Chesapeake Research Group — Pasadena, Maryland, United States
• Premier Research — Austin, Texas, United States
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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