A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty (ALLEVIATE1)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Full Abdominoplasty

The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Placebo; Drug: Cebranopadol 400 ug; Drug: Cebranopadol 200 ug

Detailed Description

This study is a Phase 3, multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain after Full Abdominoplasty. This study will be conducted in 3 phases: Screening, Treatment, and Follow-up.

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • ALLEVIATE 1 Site 001106
  • Florida
    • Miami, Florida, United States, 33014
      • ALLEVIATE 1 Site 001112
  • Texas
    • Bellaire, Texas, United States, 77401
      • ALLEVIATE 1 Site 001110
    • San Antonio, Texas, United States, 78240
      • ALLEVIATE 1 Site 001111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Scheduled to undergo full abdominoplasty procedure without liposuction or other collateral procedures, using anesthesiologic and surgical procedures planned as described in this protocol.
• Must be able to adhere to the visit schedule, complete all study assessments, and protocol requirements including self-reported questionnaires.

Key Exclusion Criteria:

• Any clinically significant disease, medical condition or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity or compromise the safety of the subject.
• Subject has a current painful condition that could confound the interpretation of efficacy, safety or tolerability data in the study, in the opinion of the investigator.
• History of allergy, hypersensitivity or intolerance to any opioid analgesics or anesthetics, including opioid-induced nausea or vomiting.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; Cebranopadol 400 ug (once daily for 2 days)	Drug: Cebranopadol 400 ug; Once daily; Other Names: TRN-228
Experimental: Treatment B; Cebranopadol 400 ug on Day 1; 200 ug on Day 2	Drug: Cebranopadol 400 ug; Once daily; Other Names: TRN-228; Drug: Cebranopadol 200 ug; Once daily on Day 2; Other Names: TRN-228
Placebo Comparator: Treatment C; Placebo (once daily for 2 days)	Drug: Placebo; Once daily for 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	Pain Numerical Rate Scale (NRS) area under the curve from 4 through 48 hours (AUC4-48)	4-48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measure:	Pain Numerical Rate Scale (NRS) AUC4-24	4-48 hours
Secondary Outcome Measure:	Number of doses of rescue medication	48 hours
Secondary Outcome Measure:	Pain NRS AUC	24-48 hours
Other Secondary Endpoint	Pain NRS	Partial AUCs: 4-12, 12-24, 24-36, 36-48, and 4-36 hours
Other Secondary Endpoint	Rescue Medication	Proportion of subjects who take at least 1 dose of rescue medication up to hours 12, 24, and 36
Other Secondary Endpoint	MOAA/S	peak sedation, total score and AUC4-48

Collaborators and Investigators

• Sponsor: Tris Pharma, Inc.
• Investigators: Principal Investigator: Harold S. Minkowitz, MD, HD Research

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Abdominoplasty
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acute Pain; 6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine
• Other Study ID Numbers: TRN-228-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No