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

Acute Pain Clinical Trial

Official 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 Abdominoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820324
• Other study ID #: CP130-3002
• Status: Completed
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: January 2017

Study information

• Verified date: September 2020
• Source: Trevena Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 pain after abdominoplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Oliceridine

• Placebo

• Morphine

Locations

Country	Name	City	State
United States	Research Site	Houston	Texas
United States	Research Site	Pasadena	California
United States	Research Site	Pasadena	Maryland
United States	Research Site	Phoenix	Arizona
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Trevena Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Secondary	Number of Respiratory Safety Events Compared to Morphine.	Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.	24 hours
Secondary	Duration of Respiratory Events Compared to Morphine.	Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.	24 hours
Secondary	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.	24 hours
Secondary	Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.		24 hours