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

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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

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

Trial contacts and locations

4

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Central trial contact

Liza Micioni

Data sourced from clinicaltrials.gov

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