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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06545097

Acronym

ALLEVIATE1

Enrollment

279

Registered

2024-08-09

Start date

2024-09-03

Completion date

2024-12-30

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

Abdominoplasty

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.

Interventions

DRUGCebranopadol 400 ug

Once daily

DRUGCebranopadol 200 ug

Once daily on Day 2

DRUGPlacebo

Once daily for 2 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Secondary Outcome Measure:	4-48 hours	Pain Numerical Rate Scale (NRS) AUC4-24
Other Secondary Endpoint	Partial AUCs: 4-12, 12-24, 24-36, 36-48, and 4-36 hours	Pain NRS

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHarold S. Minkowitz, MD

HD Research

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026