Clinical trial NCT06545097: A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty
Official title: A 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute Pain
Keywords: Abdominoplasty
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Full Abdominoplasty. This study will be conducted in 3 phases: Screening, Treatment, and Follow-up.

Eligibility 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.

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 4-48 hours
Secondary outcomes:
measure: Secondary Outcome Measure:
timeFrame: 4-48 hours
measure: Secondary Outcome Measure:
timeFrame: 48 hours
measure: Secondary Outcome Measure:
timeFrame: 24-48 hours
measure: Other Secondary Endpoint
timeFrame: Partial AUCs: 4-12, 12-24, 24-36, 36-48, and 4-36 hours
measure: Other Secondary Endpoint
timeFrame: Proportion of subjects who take at least 1 dose of rescue medication up to hours 12, 24, and 36
measure: Other Secondary Endpoint
timeFrame: peak sedation, total score and AUC4-48
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: ALLEVIATE 1 Site 001106
state: Arkansas
city: Miami
country: United States
facility: ALLEVIATE 1 Site 001112
state: Florida
city: Bellaire
country: United States
facility: ALLEVIATE 1 Site 001110
state: Texas
city: San Antonio
country: United States
facility: ALLEVIATE 1 Site 001111
state: Texas
Study officials:
affiliation: HD Research
name: Harold S. Minkowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: