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New pill could ease Post-Surgery pain without opioids

NCT ID NCT06215820

Symptom relief Sponsor: Viatris Specialty LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called MR-107A-02 for treating acute pain after bunionectomy (foot surgery). 410 adults received either the new drug, a placebo, or tramadol (a standard painkiller). The main goal was to see if MR-107A-02 provides better pain relief than placebo, measured by pain scores over time. The trial also tracked how many patients needed extra opioid pain medication.

What this could mean

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

Active substance
MR-107A-02 (a tablet for pain relief)
What this could lead to
If it works, this could offer a new option for managing acute pain after foot 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 more effective than existing painkillers, 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

410 people

The number who actually took part.

Started

Dec 2023

Finished

Sep 2024

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 years and older

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: 1. Requirement for a primary unilateral bunionectomy 2. Has an American Society of Anesthesiologists Physical Status of I, II, or III. 3. Pain Intensity (PI) using a Numeric Rating Scale (NRS-R) ≥4 at any given timepoint during the 9 hours after removal of the popliteal sciatic block 4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 9 hours after removal of the popliteal sciatic block 5. Able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions. Key Exclusion Criteria: 1. Previously dosed with this formulation of MR-107A-02. 2. Subjects with a contralateral foot bunionectomy in the past 6 months. 3. Subject has a concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the bunionectomy, and which may confound the postoperative assessments. 4. Known hypersensitivity to aspirin, NSAIDs or other medication used in the study. 5. Body mass index (BMI) \>40 kg/m2 at screening. 6. Body weight of \<43 kg at screening. 7. History of GI bleeding or peptic ulcer disease. 8. Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis. 9. A history of bleeding disorders that may affect coagulation. 10. Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.

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Conditions

The condition(s) this trial relates to.

Acute Pain Pain Pain, Postoperative

As listed by the trial registrant

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

Acute pain Pain Post operative pain

Contacts and locations

Locations

  • Investigator site 101

    Salt Lake City, Utah, 84107, United States

  • Investigator site 102

    Pasadena, Maryland, 21122, United States

  • Investigator site 103

    Anaheim, California, 92801, United States

  • Investigator site 104

    O'Fallon, Illinois, 62269, United States

  • Investigator site 105

    San Antonio, Texas, 62269, United States

  • Investigator site 106

    Houston, Texas, 77008, United States

  • Investigator site 107

    Carrollton, Texas, 75007, United States

  • Investigator site 108

    Tampa, Florida, 33613, United States

  • Investigator site 109

    Atlanta, Georgia, 30331, United States

  • Investigator site 110

    Riverside, California, 92501, United States

  • Investigator site 111

    McAllen, Texas, 78501, United States

  • Investigator site 112

    Miami, Florida, 35660, United States

  • Investigator site 113

    Bellaire, Texas, 77401, United States

  • Investigator site 114

    Sheffield, Alabama, 35660, United States

  • Investigator site 115

    Phoenix, Arizona, 85053, United States

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