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Completed

NCT Number: NCT02815709

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oliceridine

Drug

Placebo

Drug

Morphine

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Respiratory Safety Events Compared to Morphine.

    Time frame: 48 hours

  2. Duration of Respiratory Safety Events Compared to Morphine.

    Time frame: 48 hours

  3. 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.

  4. Number of Patients With Treatment-related Adverse Events.

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Trevena Inc.

Industry

Registry information

Official study title

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

Acronym: APOLLO-1

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jun 28, 2016
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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