Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy

October 10, 2025 updated by: Viatris Specialty LLC

A Multi-Center, Randomized, Double-Blind, Placebo- (Double-Dummy) and Active-Controlled, Parallel-Group Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy

MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Investigator site 114
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Investigator site 115
    • California
      • Anaheim, California, United States, 92801
        • Investigator site 103
      • Riverside, California, United States, 92501
        • Investigator site 110
    • Florida
      • Miami, Florida, United States, 35660
        • Investigator site 112
      • Tampa, Florida, United States, 33613
        • Investigator site 108
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Investigator site 109
    • Illinois
      • O'Fallon, Illinois, United States, 62269
        • Investigator site 104
    • Maryland
      • Pasadena, Maryland, United States, 21122
        • Investigator site 102
    • Texas
      • Bellaire, Texas, United States, 77401
        • Investigator site 113
      • Carrollton, Texas, United States, 75007
        • Investigator site 107
      • Houston, Texas, United States, 77008
        • Investigator site 106
      • McAllen, Texas, United States, 78501
        • Investigator site 111
      • San Antonio, Texas, United States, 62269
        • Investigator site 105
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Investigator site 101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MR-107A-02
15 mg Twice daily (BID) during in patient phase (0-48 hours following randomization) 15 mg BID dosing morning and evening, during out patient phase (5 days) .
Drug: MR-107A-02
tablet
Procedure: Bunionectomy
Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia
Active Comparator: Tramadol

50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization).

Placebo will be administered during out patient phase.
Drug: Tramadol
over-encapsulated tablet
Drug: Placebo
over-encapsulated tablet and/or tablet
Procedure: Bunionectomy
Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia
Placebo Comparator: Placebo
Placebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase.
Drug: Placebo
over-encapsulated tablet and/or tablet
Procedure: Bunionectomy
Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
Time Frame: 48 hours after randomization
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus placebo.
48 hours after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.
Time Frame: 7 days after randomization
Number of doses of opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.
7 days after randomization
Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.
Time Frame: 7 days after randomization
Proportion of subjects using no opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.
7 days after randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Summed Pain Intensity Difference (SPID) for tramadol versus placebo.
Time Frame: 48 hours after randomization
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for tramadol versus placebo.
48 hours after randomization
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol
Time Frame: 48 hours after randomization
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus tramadol.
48 hours after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Viatris Specialty LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mylan Specialty, LP

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Susanne Vogt, Viatris Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MR-107A-02-TFZ-3001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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