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

Phase 3

Completed

• Conditions: Acute Pain
• Interventions: Drug: Placebo; Drug: Oliceridine; Drug: Morphine

• Registration Number: NCT02820324
• Lead Sponsor: Trevena Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-06-30
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Disposition First Submitted: 2017-07-07
• Disposition First Submitted QC: 2017-07-07
• Disposition First Posted: 2017-07-11
• Results First Submitted: 2020-08-21
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-30
• Last Update Submitted: 2020-09-30
• Results First Posted: 2020-10-23
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 4 Placebo	Placebo	-
Treatment 1 Oliceridine	Oliceridine	-
Treatment 2 Oliceridine	Oliceridine	-
Treatment 3 Oliceridine	Oliceridine	-
Treatment 5 Morphine	Morphine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Respiratory Safety Events Compared to Morphine.	24 hours	Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
Duration of Respiratory Events Compared to Morphine.	24 hours	Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine.	24 hours	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.
Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.	24 hours

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States