A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy (ALLEVIATE2)

Tris Pharma

Status and phase: Enrolling; Phase 3

Conditions: Acute Pain

Treatments: Drug: Oxycodone IR; Drug: Cebranopadol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06423703

TRN-228-302

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups, including a placebo group

Cebranopadol

Experimental group

Description:

once daily for 3 days

Treatment:

Drug: Placebo

Drug: Cebranopadol

Oxycodone IR

Active Comparator group

Description:

four times per day for 3 days

Treatment:

Drug: Oxycodone IR

Placebo

Placebo Comparator group

Description:

three times per day 3 days (with cebranopadol); four times per day for 3 days (placebo arm)

Treatment:

Drug: Placebo