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

Last updated: September 4, 2020
Sponsor: Trevena Inc.
Overall Status: Completed

Phase

3

Condition

Acute Pain

Pain

Treatment

N/A

Clinical Study ID

NCT02815709
CP130-3001
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy andinternal 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

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 mayinterfere with the interpretation of efficacy, safety, or tolerability data obtainedin the trial, or may interfere with the absorption, distribution, metabolism, orexcretion of drugs.

  • Has previously participated in another TRV130 clinical study.

Study Design

Total Participants: 418
Study Start date:
May 01, 2016
Estimated Completion Date:
January 31, 2017

Connect with a study center

  • Research Site

    Phoenix, Arizona 85027
    United States

    Site Not Available

  • Research Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Research Site

    Pasadena, California 91105
    United States

    Site Not Available

  • Research Site

    Austin, Texas 78229
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Resarch Site

    Salt Lake City, Utah 84124
    United States

    Site Not Available

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