Status:
COMPLETED
Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Lead Sponsor:
Viatris Specialty LLC
Collaborating Sponsors:
Mylan Specialty, LP
Conditions:
Acute Pain
Post Operative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.
Eligibility Criteria
Inclusion
- Key
- Requirement for a primary unilateral bunionectomy
- Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- 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
- 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
- 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
- Previously dosed with this formulation of MR-107A-02.
- Subjects with a contralateral foot bunionectomy in the past 6 months.
- 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.
- 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 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.
Key Trial Info
Start Date :
December 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT06215820
Start Date
December 29 2023
End Date
September 30 2024
Last Update
October 14 2025
Active Locations (15)
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1
Investigator site 114
Sheffield, Alabama, United States, 35660
2
Investigator site 115
Phoenix, Arizona, United States, 85053
3
Investigator site 103
Anaheim, California, United States, 92801
4
Investigator site 110
Riverside, California, United States, 92501