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

Phase 3

Completed

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

• Registration Number: NCT06215820
• 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 bunionectomy.

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: 2024-08-24
• Study Completion: 2024-09-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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 & 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 at rest (NRS-R) 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.
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.

Trial Locations

Locations (15)

Investigator site 105; 🇺🇸 San Antonio, Texas, United States

Investigator site 101; 🇺🇸 Salt Lake City, Utah, United States

Investigator site 112; 🇺🇸 Miami, Florida, United States

Investigator site 108; 🇺🇸 Tampa, Florida, United States

Investigator site 114; 🇺🇸 Sheffield, Alabama, United States

Investigator site 115; 🇺🇸 Phoenix, Arizona, United States

Investigator site 103; 🇺🇸 Anaheim, California, United States

Investigator site 110; 🇺🇸 Riverside, California, United States

Investigator site 109; 🇺🇸 Atlanta, Georgia, United States

Investigator site 104; 🇺🇸 O'Fallon, Illinois, United States

Investigator site 102; 🇺🇸 Pasadena, Maryland, United States

Investigator site 113; 🇺🇸 Bellaire, Texas, United States

Investigator site 107; 🇺🇸 Carrollton, Texas, United States

Investigator site 106; 🇺🇸 Houston, Texas, United States

Investigator site 111; 🇺🇸 McAllen, Texas, United States