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Completed

NCT Number: NCT06545097

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

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

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ALLEVIATE 1 Site 001106, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cebranopadol 400 ug

Drug

Once daily

Other names: TRN-228

Cebranopadol 200 ug

Drug

Once daily on Day 2

Other names: TRN-228

Placebo

Drug

Once daily for 2 days

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 4-48 hours

    Pain Numerical Rate Scale (NRS) area under the curve from 4 through 48 hours (AUC4-48)

Secondary outcomes

  1. Secondary Outcome Measure:

    Time frame: 4-48 hours

    Pain Numerical Rate Scale (NRS) AUC4-24

  2. Secondary Outcome Measure:

    Time frame: 48 hours

    Number of doses of rescue medication

  3. Secondary Outcome Measure:

    Time frame: 24-48 hours

    Pain NRS AUC

  4. Other Secondary Endpoint

    Time frame: Partial AUCs: 4-12, 12-24, 24-36, 36-48, and 4-36 hours

    Pain NRS

  5. Other Secondary Endpoint

    Time frame: Proportion of subjects who take at least 1 dose of rescue medication up to hours 12, 24, and 36

    Rescue Medication

  6. Other Secondary Endpoint

    Time frame: peak sedation, total score and AUC4-48

    MOAA/S

Sponsors and collaborators

Lead sponsor

Tris Pharma, Inc.

Industry

Registry information

Official study title

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

Acronym: ALLEVIATE1

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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