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Opioid Analgesic

Cebranopadol for Acute Pain (ALLEVIATE2 Trial)

Phase 3
Recruiting
Led By Todd M Bertoch, MD
Research Sponsored by Tris Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomy and internal fixation with no collateral procedures, using anesthesiologic and surgical procedures planned
Be older than 18 years old
Must not have
Evidence of hemodynamic instability or respiratory insufficiency.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

"This trial aims to test how well and how safe Cebranopadol works for treating acute pain following a bunion removal surgery."

Who is the study for?
This trial is for individuals experiencing acute pain following a bunionectomy, which is a surgical procedure to remove bunions. Participants should meet specific health criteria set by the study's guidelines.
What is being tested?
The study aims to test the effectiveness and safety of Cebranopadol in managing post-surgical pain compared with Oxycodone IR (a known painkiller) and a placebo (a substance with no therapeutic effect).
What are the potential side effects?
Possible side effects may include nausea, dizziness, constipation, headache, and potential risk for dependency or abuse similar to other opioid medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a specific foot surgery to correct a bunion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have unstable blood pressure or trouble breathing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CebranopadolExperimental Treatment2 Interventions
once daily for 3 days
Group II: Oxycodone IRActive Control1 Intervention
four times per day for 3 days
Group III: PlaceboPlacebo Group1 Intervention
three times per day 3 days (with cebranopadol); four times per day for 3 days (placebo arm)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cebranopadol
2013
Completed Phase 3
~80
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Tris Pharma, Inc.Lead Sponsor
21 Previous Clinical Trials
4,573 Total Patients Enrolled
1 Trials studying Acute Pain
300 Patients Enrolled for Acute Pain
Todd M Bertoch, MDPrincipal InvestigatorCenExel JBR
1 Previous Clinical Trials
501 Total Patients Enrolled
~40 spots leftby Feb 2025
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