The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
279
ALLEVIATE 1 Site 001106
Little Rock, Arkansas, United States
ALLEVIATE 1 Site 001112
Miami, Florida, United States
ALLEVIATE 1 Site 001110
Bellaire, Texas, United States
ALLEVIATE 1 Site 001111
San Antonio, Texas, United States
Primary Outcome Measure
Pain Numerical Rate Scale (NRS) area under the curve from 4 through 48 hours (AUC4-48)
Time frame: 4-48 hours
Secondary Outcome Measure:
Pain Numerical Rate Scale (NRS) AUC4-24
Time frame: 4-48 hours
Secondary Outcome Measure:
Number of doses of rescue medication
Time frame: 48 hours
Secondary Outcome Measure:
Pain NRS AUC
Time frame: 24-48 hours
Other Secondary Endpoint
Pain NRS
Time frame: Partial AUCs: 4-12, 12-24, 24-36, 36-48, and 4-36 hours
Other Secondary Endpoint
Rescue Medication
Time frame: Proportion of subjects who take at least 1 dose of rescue medication up to hours 12, 24, and 36
Other Secondary Endpoint
MOAA/S
Time frame: peak sedation, total score and AUC4-48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.