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

NCT06423703 | Completed Phase 3 FDA Drug

• 1 other identifier: TRN-228-302
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Acute Pain

Keywords

Bunionectomy

Outcome Measures

Primary Outcomes (1)

• Pain NRS area under the curve: cebranopadol vs. placebo

  2-48 hours

Secondary Outcomes (3)

• Proportion of subjects who require opioid rescue medication

  1-7 Days

• Global Assessment of Satisfaction

  1-7 Days

• Total oxycodone rescue consumption

  1-7 Days

Other Outcomes (1)

• Incidence of Respiratory Safety Events

  1-7 Days

Study Arms (3)

Cebranopadol

EXPERIMENTAL

once daily for 3 days

Drug: Cebranopadol; Drug: Placebo

Oxycodone IR

ACTIVE COMPARATOR

four times per day for 3 days

Drug: Oxycodone IR

Placebo

PLACEBO COMPARATOR

four times per day for 3 days

Drug: Placebo Only

Interventions

Oxycodone IR DRUG

four times per day for 3 days

Also known as: oxycodone immediate release

Oxycodone IR

Placebo Only DRUG

four times per day for 3 days

Placebo

Placebo DRUG

three times per day for 3 days

Cebranopadol

Cebranopadol DRUG

once daily for 3 days

Also known as: TRN-228

Cebranopadol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tris Pharma, Inc.: lead

Study Sites (10)

ALLEVIATE 2 Site 001108

Sheffield, Alabama, 35660, United States

Location

ALLEVIATE 2 Site 001106

Little Rock, Arkansas, 72211, United States

Location

ALLEVIATE 2 Site 001103

Tampa, Florida, 33613, United States

Location

ALLEVIATE 2 Site 001102

Atlanta, Georgia, 30331, United States

Location

ALLEVIATE 2 Site 001107

Overland Park, Kansas, 66212, United States

Location

ALLEVIATE 2 Site 001105

Pasadena, Maryland, 21122, United States

Location

Alleviate 2 001113

Houston, Texas, 77043, United States

Location

ALLEVIATE 2 Site 001104

McAllen, Texas, 78501, United States

Location

ALLEVIATE 2 Site 001111

San Antonio, Texas, 78240, United States

Location

ALLEVIATE 2 Site 001101

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine; Oxycodone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Todd M Bertoch, MD

  Cenexel JBR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: July 18, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (10)