Cebranopadol for Acute Pain

(ALLEVIATE1 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new medication, Cebranopadol, for managing pain after tummy tuck surgery. Researchers aim to determine its efficacy in easing pain and its safety for patients. Participants will receive either a low or high dose of the medication or a placebo (a pill with no active drug). Ideal candidates for this trial are those planning to have a full tummy tuck without additional procedures. As a Phase 3 trial, this study represents the final step before FDA approval, giving participants the opportunity to help bring a potentially effective pain management solution to market.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cebranopadol is generally safe for people. In earlier studies, doses of 400 micrograms (a very small amount) were used without problems. These studies also found that cebranopadol helps reduce pain after surgery, indicating its safety.

While specific details about side effects aren't provided, the current phase of testing (Phase 3) typically follows earlier tests that deemed it safe enough for larger trials. This phase evaluates its effectiveness and monitors side effects in larger groups.

For those considering joining a trial, cebranopadol has shown promise in managing sudden pain and is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for acute pain?

Cebranopadol is unique because it targets both the nociceptin/orphanin FQ peptide receptor and the opioid receptor, offering a dual-action approach to pain relief. Unlike traditional opioids that primarily target just the opioid receptor, cebranopadol's dual mechanism could provide effective pain management with potentially fewer side effects and a lower risk of dependency. Researchers are excited about this treatment as it might offer a safer alternative to conventional opioids, addressing the need for effective pain relief while mitigating the risks associated with opioid use.

What evidence suggests that Cebranopadol might be an effective treatment for acute pain after abdominoplasty?

Studies have shown that cebranopadol effectively reduces sudden pain. In this trial, participants will receive either a 200 microgram or 400 microgram dose of cebranopadol, or a placebo. Research found that patients who took cebranopadol experienced significantly less pain after surgery compared to those who took a placebo (a pill with no active medicine). Specifically, doses of 400 micrograms proved especially effective. Cebranopadol also enabled more patients to avoid needing extra pain-relief medications, such as opioids. Overall, the findings suggest cebranopadol can be a strong option for managing post-surgical pain. ^{1 2 3 5 6}

Who Is on the Research Team?

Harold S. Minkowitz, MD

Principal Investigator

HD Research

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. trispharma.com trispharma.com/tris-pharma-announces-positive-results-from-alleviate-1-phase-3-clinical-trial-of-cebranopadol-an-investigational-first-in-class-oral-dual-nmr-agonist-for-the-treatment-of-moderate-to-severe-acute-p/

Tris Pharma Announces Positive Results from ALLEVIATE ... Study achieved primary endpoint of statistically significant reduction in pain intensity compared to placebo following abdominoplasty ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06545097

NCT06545097 | A Study of Cebranopadol for the ... The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29871387/

Cebranopadol: A Novel, First-in-Class, Strong Analgesic: ... Results: Cebranopadol doses of 400 µg and 600 µg were more effective in reducing postoperative acute pain compared to placebo, from 2 hours until approximately ...

4. drugtopics.com drugtopics.com/view/new-data-shows-cebranopadol-s-potential-in-acute-pain-management

New Data Shows Cebranopadol's Potential in Acute Pain ... Treatment with cebranopadol resulted in a significant reduction in pain intensity and a higher proportion of patients not requiring opioid ...

5. biospace.com biospace.com/press-releases/tris-pharma-announces-positive-results-from-alleviate-2-phase-3-pivotal-trial-for-cebranopadol-an-investigational-first-in-class-oral-dual-nmr-agonist-for-the-treatment-of-moderate-to-severe-acute-pain

Tris Pharma Announces Positive Results from ALLEVIATE ... Study achieved primary endpoint with cebranopadol demonstrating a statistically significant and high level of pain reduction compared to placebo.

6. trispharma.com trispharma.com/positive-phase-3-results-asra-2025/

Tris Pharma to Unveil Positive Phase 3 Results at ASRA ... Positive results from ALLEVIATE-1 Phase 3 pivotal trial for cebranopadol will be presented that demonstrate statistically significant pain reduction compared ...