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New Once-Daily painkiller could reduce opioid use after surgery

NCT ID NCT06423703

Symptom relief Sponsor: Tris Pharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 3 trial tested a new drug called cebranopadol (TRN-228) for moderate to severe acute pain after bunionectomy. 240 participants received either cebranopadol once daily, oxycodone four times daily, or placebo for three days. The study measured pain relief and whether patients needed extra opioid rescue medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cebranopadol (also called TRN-228)
What this could lead to
If successful, cebranopadol could provide a new once-daily option for managing acute pain after surgery, potentially reducing the need for opioid rescue medication.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove significantly better than placebo or existing treatments, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

240 people

The number who actually took part.

Started

Jul 2024

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Acute Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute pain

Contacts and locations

Locations

  • ALLEVIATE 2 Site 001101

    Salt Lake City, Utah, 84107, United States

  • ALLEVIATE 2 Site 001102

    Atlanta, Georgia, 30331, United States

  • ALLEVIATE 2 Site 001103

    Tampa, Florida, 33613, United States

  • ALLEVIATE 2 Site 001104

    McAllen, Texas, 78501, United States

  • ALLEVIATE 2 Site 001105

    Pasadena, Maryland, 21122, United States

  • ALLEVIATE 2 Site 001106

    Little Rock, Arkansas, 72211, United States

  • ALLEVIATE 2 Site 001107

    Overland Park, Kansas, 66212, United States

  • ALLEVIATE 2 Site 001108

    Sheffield, Alabama, 35660, United States

  • ALLEVIATE 2 Site 001111

    San Antonio, Texas, 78240, United States

  • Alleviate 2 001113

    Houston, Texas, 77043, United States

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