Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy
NCT ID: NCT06215820
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
410 participants
INTERVENTIONAL
2023-12-29
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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) .
MR-107A-02
tablet
Bunionectomy
Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia
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.
Tramadol
over-encapsulated tablet
Placebo
over-encapsulated tablet and/or tablet
Bunionectomy
Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia
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.
Placebo
over-encapsulated tablet and/or tablet
Bunionectomy
Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia
Interventions
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MR-107A-02
tablet
Tramadol
over-encapsulated tablet
Placebo
over-encapsulated tablet and/or tablet
Bunionectomy
Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Mylan Specialty, LP
INDUSTRY
Viatris Specialty LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Susanne Vogt
Role: STUDY_DIRECTOR
Viatris Inc.
Locations
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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 112
Miami, Florida, United States
Investigator site 108
Tampa, Florida, 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
Investigator site 105
San Antonio, Texas, United States
Investigator site 101
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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MR-107A-02-TFZ-3001
Identifier Type: -
Identifier Source: org_study_id
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