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
1 other identifier
interventional
410
1 country
15
Brief Summary
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2023
Shorter than P25 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2023
CompletedStudy Start
First participant enrolled
December 29, 2023
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedOctober 14, 2025
October 1, 2025
8 months
December 22, 2023
October 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus placebo.
48 hours after randomization
Secondary Outcomes (2)
Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.
7 days after randomization
Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.
7 days after randomization
Other Outcomes (2)
Summed Pain Intensity Difference (SPID) for tramadol versus placebo.
48 hours after randomization
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol
48 hours after randomization
Study Arms (3)
MR-107A-02
EXPERIMENTAL15 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
ACTIVE COMPARATOR50 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 COMPARATORPlacebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase.
Interventions
Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viatris Specialty LLClead
- Mylan Specialty, LPcollaborator
Study Sites (15)
Investigator site 114
Sheffield, Alabama, 35660, United States
Investigator site 115
Phoenix, Arizona, 85053, United States
Investigator site 103
Anaheim, California, 92801, United States
Investigator site 110
Riverside, California, 92501, United States
Investigator site 112
Miami, Florida, 35660, United States
Investigator site 108
Tampa, Florida, 33613, United States
Investigator site 109
Atlanta, Georgia, 30331, United States
Investigator site 104
O'Fallon, Illinois, 62269, United States
Investigator site 102
Pasadena, Maryland, 21122, United States
Investigator site 113
Bellaire, Texas, 77401, United States
Investigator site 107
Carrollton, Texas, 75007, United States
Investigator site 106
Houston, Texas, 77008, United States
Investigator site 111
McAllen, Texas, 78501, United States
Investigator site 105
San Antonio, Texas, 62269, United States
Investigator site 101
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Susanne Vogt
Viatris Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2023
First Posted
January 22, 2024
Study Start
December 29, 2023
Primary Completion
August 24, 2024
Study Completion
September 30, 2024
Last Updated
October 14, 2025
Record last verified: 2025-10