Cebranopadol for treating pain after bunion surgery

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

This study is testing if cebranopadol can help people manage pain after bunion surgery better than oxycodone or a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tris Pharma, Inc. (industry)
• Locations: 10 sites (Sheffield, Alabama and 9 other locations)
• Trial ID: NCT06423703 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the efficacy and safety of cebranopadol in managing acute postoperative pain following a bunionectomy. The study is multicenter, randomized, double-blind, and includes both placebo and active control groups, specifically oxycodone IR. Participants will undergo a screening phase, followed by a treatment phase where they will receive either cebranopadol, oxycodone, or a placebo, and will be monitored during a follow-up phase to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals scheduled for a primary unilateral bunionectomy with first metatarsal osteotomy and no additional surgical procedures.

Not a fit: Patients with significant comorbid conditions or secondary painful conditions unrelated to the bunion may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide effective pain relief for patients recovering from bunion surgery.

How similar studies have performed: Other studies have shown promise in using cebranopadol for pain management, indicating potential success for this approach.

Eligibility criteria

Key Inclusion Criteria Before Surgery:

* Scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomy and internal fixation with no collateral procedures, using anesthesiologic and surgical procedures planned.
* Must be able to adhere to the visit schedule, complete all study assessments and protocol requirements, including self-reported questionnaires.

Key Exclusion Criteria Before Surgery:

* Any clinically significant disease, medical condition, or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity, or compromise the safety of the subject.
* Secondary (i.e., unrelated to bunion) current painful condition that could confound the interpretation of efficacy, safety, or tolerability data in the study, in the opinion of the investigator.
* Subjects who require any analgesic for secondary (i.e., unrelated to bunion) painful condition that might impact the subject's ability to properly assess their postoperative pain, or that may require treatment during the Treatment Phase.
* History of allergy or hypersensitivity to any opioid analgesics, anesthetics, ibuprofen, or other NSAIDs.

Immediate Postoperative Exclusion Criteria:

* 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.

Where this trial is running

Sheffield, Alabama and 9 other locations

• ALLEVIATE 2 Site 001108 — Sheffield, Alabama, United States (RECRUITING)
• ALLEVIATE 2 Site 001106 — Little Rock, Arkansas, United States (RECRUITING)
• ALLEVIATE 2 Site 001103 — Tampa, Florida, United States (RECRUITING)
• ALLEVIATE 2 Site 001102 — Atlanta, Georgia, United States (RECRUITING)
• ALLEVIATE 2 Site 001107 — Overland Park, Kansas, United States (RECRUITING)
• ALLEVIATE 2 Site 001105 — Pasadena, Maryland, United States (RECRUITING)
• Alleviate 2 001113 — Houston, Texas, United States (RECRUITING)
• ALLEVIATE 2 Site 001104 — McAllen, Texas, United States (RECRUITING)
• ALLEVIATE 2 Site 001111 — San Antonio, Texas, United States (RECRUITING)
• ALLEVIATE 2 Site 001101 — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Principal investigator: Todd M Bertoch, MD — CenExel JBR
• Study coordinator: Liza Micioni

Conditions: Acute Pain, Bunionectomy