NCT06215820

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Viatris Specialty LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Acute Pain
• Post Operative Pain
• Pain

Interventions

Type	Name	Description
DRUG	MR-107A-02	tablet
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

Timeline

• Start date: 2023-12-29
• Primary completion: 2024-08-24
• Completion: 2024-09-30
• First posted: 2024-01-22
• Last updated: 2025-10-14

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study