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

NCT06423703 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-01-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.

Conditions

  • Acute Pain

Interventions

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

Sponsors & Collaborators

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Todd M Bertoch, MD · Cenexel JBR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-18
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06423703 on ClinicalTrials.gov