Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06215820
Status:
COMPLETED
Last Update Posted:
2025-10-14
First Post:
2023-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2025-08-19', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2023-12-22', 'studyFirstSubmitQcDate': '2024-01-10', 'dispFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Summed Pain Intensity Difference (SPID) for tramadol versus placebo.', 'timeFrame': '48 hours after randomization', 'description': 'SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for tramadol versus placebo.'}, {'measure': 'Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol', 'timeFrame': '48 hours after randomization', 'description': 'SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus tramadol.'}], 'primaryOutcomes': [{'measure': 'Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.', 'timeFrame': '48 hours after randomization', 'description': 'SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus placebo.'}], 'secondaryOutcomes': [{'measure': 'Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.', 'timeFrame': '7 days after randomization', 'description': 'Number of doses of opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.'}, {'measure': 'Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.', 'timeFrame': '7 days after randomization', 'description': 'Proportion of subjects using no opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain'], 'conditions': ['Acute Pain', 'Post Operative Pain', 'Pain']}, 'descriptionModule': {'briefSummary': 'MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Requirement for a primary unilateral bunionectomy\n2. Has an American Society of Anesthesiologists Physical Status of I, II, or III.\n3. 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\n4. 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\n5. 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.\n\nKey Exclusion Criteria:\n\n1. Previously dosed with this formulation of MR-107A-02.\n2. Subjects with a contralateral foot bunionectomy in the past 6 months.\n3. 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.\n4. Known hypersensitivity to aspirin, NSAIDs or other medication used in the study.\n5. Body mass index (BMI) \\>40 kg/m2 at screening.\n6. Body weight of \\<43 kg at screening.\n7. History of GI bleeding or peptic ulcer disease.\n8. Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.\n9. A history of bleeding disorders that may affect coagulation.\n10. Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening."}, 'identificationModule': {'nctId': 'NCT06215820', 'briefTitle': 'Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MR-107A-02-TFZ-3001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MR-107A-02', 'description': '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) .', 'interventionNames': ['Drug: MR-107A-02', 'Procedure: Bunionectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol', 'description': '50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization).\n\nPlacebo will be administered during out patient phase.', 'interventionNames': ['Drug: Tramadol', 'Drug: Placebo', 'Procedure: Bunionectomy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo', 'Procedure: Bunionectomy']}], 'interventions': [{'name': 'MR-107A-02', 'type': 'DRUG', 'description': 'tablet', 'armGroupLabels': ['MR-107A-02']}, {'name': 'Tramadol', 'type': 'DRUG', 'description': 'over-encapsulated tablet', 'armGroupLabels': ['Tramadol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'over-encapsulated tablet and/or tablet', 'armGroupLabels': ['Placebo', 'Tramadol']}, {'name': 'Bunionectomy', 'type': 'PROCEDURE', 'description': 'Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia', 'armGroupLabels': ['MR-107A-02', 'Placebo', 'Tramadol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigator site 114', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator site 115', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Investigator site 103', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92501', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Investigator site 110', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '35660', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator site 112', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator site 108', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigator site 109', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '62269', 'city': "O'Fallon", 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator site 104', 'geoPoint': {'lat': 38.59227, 'lon': -89.91121}}, {'zip': '21122', 'city': 'Pasadena', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigator site 102', 'geoPoint': {'lat': 39.119, 'lon': -76.57108}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 113', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75007', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 107', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 106', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78501', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 111', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '62269', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 105', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigator site 101', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Susanne Vogt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Viatris Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viatris Specialty LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mylan Specialty, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}