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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-03

Study Completion Date

2024-12-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A

Cebranopadol 400 ug (once daily for 2 days)

Group Type EXPERIMENTAL

Cebranopadol 400 ug

Intervention Type DRUG

Once daily

Treatment B

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

Group Type EXPERIMENTAL

Cebranopadol 400 ug

Intervention Type DRUG

Once daily

Cebranopadol 200 ug

Intervention Type DRUG

Once daily on Day 2

Treatment C

Placebo (once daily for 2 days)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily for 2 days

Interventions

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Cebranopadol 400 ug

Once daily

Intervention Type DRUG

Cebranopadol 200 ug

Once daily on Day 2

Intervention Type DRUG

Placebo

Once daily for 2 days

Intervention Type DRUG

Other Intervention Names

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TRN-228 TRN-228

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No