A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty

Phase 3

Active, not recruiting

• Conditions: Acute Pain
• Interventions: Drug: Placebo; Drug: Cebranopadol

• Registration Number: NCT06545097
• Lead Sponsor: Tris Pharma, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Study Start: 2024-09-03
• Status Verified: 2024-12
• Primary Completion: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment C	Placebo	Placebo
Treatment A	Cebranopadol	Cebranopadol 400/400 ug (once daily)
Treatment B	Cebranopadol	Cebranopadol 200 ug (once daily)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measure:	24-48 hours	Pain NRS AUC
Other Secondary Endpoint	peak sedation, total score and AUC4-48	MOAA/S

Trial Locations

Locations (4)

ALLEVIATE 1 Site 001106; 🇺🇸 Little Rock, Arkansas, United States

ALLEVIATE 1 Site 001110; 🇺🇸 Bellaire, Texas, United States

ALLEVIATE 1 Site 001112; 🇺🇸 Miami, Florida, United States

ALLEVIATE 1 Site 001111; 🇺🇸 San Antonio, Texas, United States