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

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 Herniorrhaphy

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 579
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Investigator site 210
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Investigator site 213
  • California
    • Anaheim, California, United States, 92801
      • Investigator site 202
    • Bakersfield, California, United States, 93301
      • Investigator site 222
    • Riverside, California, United States, 92501
      • Investigator site 208
  • Florida
    • Miami, Florida, United States, 33014
      • Investigator site 211
    • Tampa, Florida, United States, 33613
      • Investigator site 206
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Investigator site 207
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Investigator site 205
  • Texas
    • Bellaire, Texas, United States, 77401
      • Investigator site 212
    • Carrollton, Texas, United States, 75006
      • Investigator site 215
    • Houston, Texas, United States, 77008
      • Investigator site 204
    • McAllen, Texas, United States, 78501
      • Investigator site 216
    • San Antonio, Texas, United States, 78229
      • Investigator site 219
    • San Antonio, Texas, United States, 78240
      • Investigator site 203
    • San Antonio, Texas, United States, 78258
      • Investigator site 214
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Investigator site 201
  • Wisconsin
    • Eau Claire, Wisconsin, United States, 54701
      • Investigator site 224

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

1. Requirement for unilateral open inguinal herniorrhaphy with mesh under general anesthesia.

3. Has an American Society of Anesthesiologists Physical Status of I, II, or III.

4. Pain Intensity (PI) using NRS-R ≥4 at any given timepoint during the 5 hours following end of surgery in the eligibility assessment as well as in the baseline assessment (NRS-R and NRS-A) immediately pre-dosing.

5. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following end of surgery.

6. 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.

Main Exclusion Criteria:

1. Previously dosed with this formulation of MR 107A 02.
2. Had any prior inguinal hernia repair in the past 24 months.
3. Has a planned concurrent surgical procedure (e.g., bilateral herniorrhaphy).
4. Has a pre-existing 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 herniorrhaphy, and which may confound the postoperative assessments.
5. Known hypersensitivity to aspirin, NSAIDs, or other medication used in the study.
6. Body mass index (BMI) >40 kg/m2 at screening.
7. Body weight of <43 kg (105.8 lbs) at screening.
8. History of GI bleeding or peptic ulcer disease.
9. Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.
10. A history of bleeding disorders that may affect coagulation.
11. 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: Herniorrhaphy; Unilateral open inguinal herniorrhaphy with mesh under general 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: Herniorrhaphy; Unilateral open inguinal herniorrhaphy with mesh under general 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: Herniorrhaphy; Unilateral open inguinal herniorrhaphy with mesh under general 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 with activity (NRS-A) 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
Summed Pain Intensity Difference (SPID) for tramadol versus placebo.	SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for tramadol versus placebo.	7 days after randomization
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol	SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) 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): January 31, 2025
• Study Completion (Actual): March 12, 2025

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 (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

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; Surgical Procedures, Operative; Amines; Alcohols; Plastic Surgery Procedures; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Tramadol; Herniorrhaphy
• Other Study ID Numbers: MR-107A-02-TFZ-3002

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