The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.
This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled parallel-group study to evaluate the efficacy and safety of cebranopadol in the treatment of postoperative pain following primary unilateral bunionectomy with first metatarsal osteotomy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
once daily for 3 days
four times per day for 3 days
four times per day for 3 days
ALLEVIATE 2 Site 001108
Sheffield, Alabama, United States
ALLEVIATE 2 Site 001106
Little Rock, Arkansas, United States
ALLEVIATE 2 Site 001103
Tampa, Florida, United States
ALLEVIATE 2 Site 001102
Pain NRS area under the curve: cebranopadol vs. placebo
Time frame: 2-48 hours
Proportion of subjects who require opioid rescue medication
Time frame: 1-7 Days
Global Assessment of Satisfaction
Time frame: 1-7 Days
Total oxycodone rescue consumption
Time frame: 1-7 Days
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three times per day for 3 days
Atlanta, Georgia, United States
ALLEVIATE 2 Site 001107
Overland Park, Kansas, United States
ALLEVIATE 2 Site 001105
Pasadena, Maryland, United States
Alleviate 2 001113
Houston, Texas, United States
ALLEVIATE 2 Site 001104
McAllen, Texas, United States
ALLEVIATE 2 Site 001111
San Antonio, Texas, United States
ALLEVIATE 2 Site 001101
Salt Lake City, Utah, United States