Cebranopadol for Acute Pain

(ALLEVIATE1 Trial)

Recruiting at 3 trial locations

Overseen By Liza Micioni

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Tris Pharma, Inc.

Must not be taking: Opioid analgesics

Disqualifiers: Significant disease, Painful condition, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Harold S. Minkowitz, MD

Principal Investigator

HD Research

Eligibility Criteria

This trial is for individuals experiencing acute pain following an abdominoplasty, commonly known as a tummy tuck. Participants should meet certain health standards but specific inclusion and exclusion criteria are not listed.

Inclusion Criteria

I can attend all scheduled visits and complete all study tasks.

I am scheduled for a full tummy tuck without liposuction or other surgeries, as outlined.

Exclusion Criteria

I do not have any painful conditions that could affect study results.

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

History of allergy, hypersensitivity or intolerance to any opioid analgesics or anesthetics, including opioid-induced nausea or vomiting

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Cebranopadol or placebo for the treatment of acute pain after abdominoplasty

48 hours

Daily monitoring during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Cebranopadol

Trial Overview The study aims to test the effectiveness and safety of Cebranopadol in managing acute pain after abdominoplasty surgery. It will compare results from patients taking Cebranopadol against those given a placebo.

Participant Groups

Group I: Treatment B Experimental Treatment 1 Intervention

Cebranopadol 200 ug (once daily)

Group II: Treatment A Experimental Treatment 1 Intervention

Cebranopadol 400/400 ug (once daily)

Group III: Treatment C Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Tris Pharma, Inc.

Lead Sponsor

Trials

22

Recruited

4,800+