Status:
COMPLETED
A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty
Lead Sponsor:
Tris Pharma, Inc.
Conditions:
Acute Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.
Detailed 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 Fu...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT06545097
Start Date
September 3 2024
End Date
December 30 2024
Last Update
January 8 2026
Active Locations (4)
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1
ALLEVIATE 1 Site 001106
Little Rock, Arkansas, United States, 72211
2
ALLEVIATE 1 Site 001112
Miami, Florida, United States, 33014
3
ALLEVIATE 1 Site 001110
Bellaire, Texas, United States, 77401
4
ALLEVIATE 1 Site 001111
San Antonio, Texas, United States, 78240