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

Phase 3CompletedNCT02820324

Trevena Inc.407 enrolled

Overview

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 pain after abdominoplasty.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

407

Conditions

Acute Pain

Interventions

OliceridineDRUG

PlaceboDRUG

MorphineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Has undergone abdominoplasty 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.

Locations (5)

Research Site

Phoenix, Arizona, United States

Research Site

Pasadena, California, United States

Research Site

Pasadena, Maryland, United States

Research Site

Houston, Texas, United States

Research Site

Outcomes

Primary Outcomes

Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.

The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit.

Time frame: 24 hours

Secondary Outcomes

Number of Respiratory Safety Events Compared to Morphine.

Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.

Time frame: 24 hours

Duration of Respiratory Events Compared to Morphine.

Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.

Time frame: 24 hours

Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine.

Odds ratio of 24-hour responder analysis versus morphine. Number of patients who responded to study medication at the 24-hr NPRS assessment is captured in the primary outcome measure.

Time frame: 24 hours

Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.

Time frame: 24 hours

Data from ClinicalTrials.gov

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