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

Phase 3

Completed

• Conditions: Acute Pain; Post Operative Pain; Pain
• Interventions: Drug: MR-107A-02; Drug: Tramadol; Drug: Placebo

• Registration Number: NCT06215859
• Lead Sponsor: Viatris Specialty LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-22
• Study Start: 2023-12-29
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-22
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 579

Inclusion Criteria

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

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

3. 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.

4. 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.

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.

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MR-107A-02	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) .
Tramadol	Placebo	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.
Placebo	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.
Tramadol	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.

Primary Outcome Measures

Name	Time	Method
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.	48 hours after randomization	SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for MR-107A-02 versus placebo.

Secondary Outcome Measures

Name	Time	Method
Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.	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.
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol	48 hours after randomization	SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for MR-107A-02 versus tramadol.
Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.	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.
Summed Pain Intensity Difference (SPID) for tramadol versus placebo.	7 days after randomization	SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for tramadol versus placebo.

Trial Locations

Locations (18)

Investigator site 213; 🇺🇸 Phoenix, Arizona, United States

Investigator site 212; 🇺🇸 Bellaire, Texas, United States

Investigator site 204; 🇺🇸 Houston, Texas, United States

Investigator site 202; 🇺🇸 Anaheim, California, United States

Investigator site 206; 🇺🇸 Tampa, Florida, United States

Investigator site 207; 🇺🇸 Atlanta, Georgia, United States

Investigator site 216; 🇺🇸 McAllen, Texas, United States

Investigator site 219; 🇺🇸 San Antonio, Texas, United States

Investigator site 203; 🇺🇸 San Antonio, Texas, United States

Investigator site 214; 🇺🇸 San Antonio, Texas, United States

Investigator site 211; 🇺🇸 Miami, Florida, United States

Investigator site 205; 🇺🇸 Wichita, Kansas, United States

Investigator site 201; 🇺🇸 Salt Lake City, Utah, United States

Investigator site 224; 🇺🇸 Eau Claire, Wisconsin, United States

Investigator site 215; 🇺🇸 Carrollton, Texas, United States

Investigator site 210; 🇺🇸 Sheffield, Alabama, United States

Investigator site 222; 🇺🇸 Bakersfield, California, United States

Investigator site 208; 🇺🇸 Riverside, California, United States