A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy
- Registration Number
- NCT06423703
- Lead Sponsor
- Tris Pharma, Inc.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
Not provided
- Surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study.
- Deviation from the surgical, postsurgical, or anesthetic protocol that could confound the interpretation of efficacy, safety, or tolerability data in the study.
- Evidence of hemodynamic instability or respiratory insufficiency.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxycodone IR Oxycodone IR four times per day for 3 days Cebranopadol Cebranopadol once daily for 3 days Cebranopadol Placebo once daily for 3 days Placebo Placebo three times per day 3 days (with cebranopadol); four times per day for 3 days (placebo arm)
- Primary Outcome Measures
Name Time Method Pain NRS area under the curve: cebranopadol vs. placebo 2-48 hours
- Secondary Outcome Measures
Name Time Method Proportion of subjects who require opioid rescue medication 1-7 Days Global Assessment of Satisfaction 1-7 Days Total oxycodone rescue consumption 1-7 Days
Trial Locations
- Locations (10)
Alleviate 2 001113
🇺🇸Houston, Texas, United States
ALLEVIATE 2 Site 001111
🇺🇸San Antonio, Texas, United States
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
🇺🇸Atlanta, Georgia, United States
ALLEVIATE 2 Site 001107
🇺🇸Overland Park, Kansas, United States
ALLEVIATE 2 Site 001105
🇺🇸Pasadena, Maryland, United States
ALLEVIATE 2 Site 001104
🇺🇸McAllen, Texas, United States
ALLEVIATE 2 Site 001101
🇺🇸Salt Lake City, Utah, United States