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

NCT06545097 | Completed Phase 3 FDA Drug

• 1 other identifier: TRN-228-301
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Acute Pain

Keywords

Abdominoplasty

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

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

  4-48 hours

Secondary Outcomes (6)

• Secondary Outcome Measure:

  4-48 hours

• Secondary Outcome Measure:

  48 hours

• Secondary Outcome Measure:

  24-48 hours

• Other Secondary Endpoint

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

• Other Secondary Endpoint

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

Study Arms (3)

Treatment A

EXPERIMENTAL

Cebranopadol 400 ug (once daily for 2 days)

Drug: Cebranopadol 400 ug

Treatment B

EXPERIMENTAL

Cebranopadol 400 ug on Day 1; 200 ug on Day 2

Drug: Cebranopadol 400 ug; Drug: Cebranopadol 200 ug

Treatment C

PLACEBO COMPARATOR

Placebo (once daily for 2 days)

Drug: Placebo

Interventions

Cebranopadol 400 ug DRUG

Once daily

Also known as: TRN-228

Treatment A; Treatment B

Cebranopadol 200 ug DRUG

Once daily on Day 2

Also known as: TRN-228

Treatment B

Placebo DRUG

Once daily for 2 days

Treatment C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tris Pharma, Inc.: lead

Study Sites (4)

ALLEVIATE 1 Site 001106

Little Rock, Arkansas, 72211, United States

Location

ALLEVIATE 1 Site 001112

Miami, Florida, 33014, United States

Location

ALLEVIATE 1 Site 001110

Bellaire, Texas, 77401, United States

Location

ALLEVIATE 1 Site 001111

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine

Condition Hierarchy (Ancestors)

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

Study Officials

• Harold S. Minkowitz, MD

  HD Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: September 3, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (4)