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

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: Completed
• Conditions: Pain; Acute Pain; Post Operative Pain
• Intervention / Treatment: Drug: MR-107A-02; Drug: Tramadol; Drug: Placebo; Procedure: Bunionectomy

• Study Type: Interventional
• Enrollment (Actual): 410
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.	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

Outcome Measure	Measure Description	Time Frame
Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.	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.	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

Outcome Measure	Measure Description	Time Frame
Summed Pain Intensity Difference (SPID) for tramadol versus placebo.	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	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

• Sponsor: Viatris Specialty LLC
• Collaborators: Mylan Specialty, LP
• Investigators: Study Director: Susanne Vogt, Viatris Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2023
• Primary Completion (Actual): August 24, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pain, Postoperative; Acute Pain; Organic Chemicals; Lipids; Amines; Alcohols; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Tramadol
• Other Study ID 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