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

Acute Pain Clinical Trial

— ALLEVIATE2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423703
• Other study ID #: TRN-228-302
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Tris Pharma, Inc.
• Contact: Antonio Pardo, MD
• Phone: 732-823-4755
• Email: clinicalaffairs[@]trispharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Cebranopadol
once daily for 3 days
• Oxycodone IR
four times per day for 3 days
• Placebo
three times per day 3 days (with cebranopadol), four times per day for 3 days (placebo arm)

Locations

Country	Name	City	State
United States	ALLEVIATE 2 Site 001102	Atlanta	Georgia
United States	ALLEVIATE 2 Site 001106	Little Rock	Arkansas
United States	ALLEVIATE 2 Site 001104	McAllen	Texas
United States	ALLEVIATE 2 Site 001107	Overland Park	Kansas
United States	ALLEVIATE 2 Site 001105	Pasadena	Maryland
United States	ALLEVIATE 2 Site 001101	Salt Lake City	Utah
United States	ALLEVIATE 2 Site 001108	Sheffield	Alabama
United States	ALLEVIATE 2 Site 001103	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tris Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Respiratory Safety Events		0-72 hours
Primary	Pain NRS area under the curve: cebranopadol vs. placebo		2-48 hours
Secondary	Proportion of subjects who require opioid rescue medication		0-72 hours
Secondary	Global Assessment of Satisfaction		0-72 hours
Secondary	Total oxycodone rescue consumption		0-72 hours