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

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.

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.