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

NCT06215820 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2025-10-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Mylan Specialty, LP

    collaborator INDUSTRY

  • Viatris Specialty LLC

    lead INDUSTRY

Principal Investigators

  • Susanne Vogt · Viatris Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-29
Primary Completion
2024-08-24
Completion
2024-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06215820 on ClinicalTrials.gov