NCT06423703

A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Primary Unilateral Bunionectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Cebranopadol	once daily for 3 days
DRUG	Oxycodone IR	four times per day for 3 days
DRUG	Placebo Only	four times per day for 3 days
DRUG	Placebo	three times per day for 3 days

Timeline

• Start date: 2024-07-18
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-05-21
• Last updated: 2026-01-26

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study