A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty (ALLEVIATE1)

Tris Pharma

Status and phase: Not yet enrolling; Phase 3

Conditions: Acute Pain

Treatments: Drug: Cebranopadol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06545097

TRN-228-301

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

Treatment A

Experimental group

Description:

Cebranopadol 400/400 ug (once daily)

Treatment:

Drug: Cebranopadol

Drug: Cebranopadol

Treatment B

Experimental group

Description:

Cebranopadol 200 ug (once daily)

Treatment:

Drug: Cebranopadol

Drug: Cebranopadol

Treatment C

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo