Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy (APOLLO-1)

September 4, 2020 updated by: Trevena Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

418

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85027
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Pasadena, California, United States, 91105
        • Research Site
    • Maryland
      • Pasadena, Maryland, United States, 21122
        • Research Site
    • Texas
      • Austin, Texas, United States, 78229
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Resarch Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Treatment 1 Oliceridine
Drug: Oliceridine
Experimental: Treatment 2 Oliceridine
Drug: Oliceridine
Experimental: Treatment 3 Oliceridine
Drug: Oliceridine
Active Comparator: Morphine
Drug: Morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Respiratory Safety Events Compared to Morphine.
Time Frame: 48 hours
48 hours
Duration of Respiratory Safety Events Compared to Morphine.
Time Frame: 48 hours
48 hours
Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.
Time Frame: 48 hours
Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure.
48 hours
Number of Patients With Treatment-related Adverse Events.
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trevena Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP130-3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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