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

NCT06215859 | Completed Phase 3 FDA Drug

• 1 other identifier: MR-107A-02-TFZ-3002
• Study Type: interventional
• Target: 579
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Acute Pain; Post Operative Pain; Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.

  7 days after randomization

• Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.

  7 days after randomization

• Summed Pain Intensity Difference (SPID) for tramadol versus placebo.

  7 days after randomization

• Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol

  48 hours after randomization

Study Arms (3)

MR-107A-02

EXPERIMENTAL

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; Procedure: Herniorrhaphy

Tramadol

ACTIVE COMPARATOR

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; Drug: Placebo; Procedure: Herniorrhaphy

Placebo

PLACEBO COMPARATOR

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; Procedure: Herniorrhaphy

Interventions

Herniorrhaphy PROCEDURE

Unilateral open inguinal herniorrhaphy with mesh under general anesthesia

MR-107A-02; Placebo; Tramadol

MR-107A-02 DRUG

tablet

MR-107A-02

Tramadol DRUG

over-encapsulated tablet

Tramadol

Placebo DRUG

over-encapsulated tablet and/or tablet

Placebo; Tramadol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Requirement for unilateral open inguinal herniorrhaphy with mesh under general anesthesia.
• \. Has an American Society of Anesthesiologists Physical Status of I, II, or III.
• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

• Previously dosed with this formulation of MR 107A 02.
• Had any prior inguinal hernia repair in the past 24 months.
• Has a planned concurrent surgical procedure (e.g., bilateral herniorrhaphy).
• 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.
• Known hypersensitivity to aspirin, NSAIDs, or other medication used in the study.
• Body mass index (BMI) \>40 kg/m2 at screening.
• Body weight of \<43 kg (105.8 lbs) at screening.
• History of GI bleeding or peptic ulcer disease.
• Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.
• A history of bleeding disorders that may affect coagulation.
• Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.

Sponsors & Collaborators

• Viatris Specialty LLC: lead
• Mylan Specialty, LP: collaborator

Study Sites (18)

Investigator site 210

Sheffield, Alabama, 35660, United States

Location

Investigator site 213

Phoenix, Arizona, 85053, United States

Location

Investigator site 202

Anaheim, California, 92801, United States

Location

Investigator site 222

Bakersfield, California, 93301, United States

Location

Investigator site 208

Riverside, California, 92501, United States

Location

Investigator site 211

Miami, Florida, 33014, United States

Location

Investigator site 206

Tampa, Florida, 33613, United States

Location

Investigator site 207

Atlanta, Georgia, 30331, United States

Location

Investigator site 205

Wichita, Kansas, 67214, United States

Location

Investigator site 212

Bellaire, Texas, 77401, United States

Location

Investigator site 215

Carrollton, Texas, 75006, United States

Location

Investigator site 204

Houston, Texas, 77008, United States

Location

Investigator site 216

McAllen, Texas, 78501, United States

Location

Investigator site 219

San Antonio, Texas, 78229, United States

Location

Investigator site 203

San Antonio, Texas, 78240, United States

Location

Investigator site 214

San Antonio, Texas, 78258, United States

Location

Investigator site 201

Salt Lake City, Utah, 84107, United States

Location

Investigator site 224

Eau Claire, Wisconsin, 54701, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Pain

Interventions

Tramadol; Herniorrhaphy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Susanne Vogt

  Viatris Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 22, 2024
• Study Start: December 29, 2023
• Primary Completion: January 31, 2025
• Study Completion: March 12, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (18)