Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-04 @ 3:28 PM
Study NCT ID:
NCT06215859
Status:
COMPLETED
Last Update Posted:
2025-05-04
First Post:
2023-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy
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': 579}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2023-12-22', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'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 with activity (NRS-A) 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.'}, {'measure': 'Summed Pain Intensity Difference (SPID) for tramadol versus placebo.', 'timeFrame': '7 days after randomization', 'description': 'SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) 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 with activity (NRS-A) for MR-107A-02 versus tramadol.'}]}, 'oversightModule': {'isUsExport': False, '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 herniorrhaphy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n1\\. Requirement for unilateral open inguinal herniorrhaphy with mesh under general anesthesia.\n\n3\\. Has an American Society of Anesthesiologists Physical Status of I, II, or III.\n\n4\\. Pain Intensity (PI) using NRS-R ≥4 at any given timepoint during the 5 hours following end of surgery in the eligibility assessment as well as in the baseline assessment (NRS-R and NRS-A) immediately pre-dosing.\n\n5\\. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following end of surgery.\n\n6\\. 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\nMain Exclusion Criteria:\n\n1. Previously dosed with this formulation of MR 107A 02.\n2. Had any prior inguinal hernia repair in the past 24 months.\n3. Has a planned concurrent surgical procedure (e.g., bilateral herniorrhaphy).\n4. Has a pre-existing 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 herniorrhaphy, and which may confound the postoperative assessments.\n5. Known hypersensitivity to aspirin, NSAIDs, or other medication used in the study.\n6. Body mass index (BMI) \\>40 kg/m2 at screening.\n7. Body weight of \\<43 kg (105.8 lbs) at screening.\n8. History of GI bleeding or peptic ulcer disease.\n9. Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.\n10. A history of bleeding disorders that may affect coagulation.\n11. Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening."}, 'identificationModule': {'nctId': 'NCT06215859', 'briefTitle': 'Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': '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 Herniorrhaphy', 'orgStudyIdInfo': {'id': 'MR-107A-02-TFZ-3002'}}, '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']}, {'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']}, {'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']}], '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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigator site 210', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator site 213', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Investigator site 202', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Investigator site 222', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92501', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Investigator site 208', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator site 211', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator site 206', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigator site 207', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigator site 205', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 212', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75006', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 215', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 204', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78501', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 216', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 219', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 203', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator site 214', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigator site 201', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '54701', 'city': 'Eau Claire', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Investigator site 224', 'geoPoint': {'lat': 44.81135, 'lon': -91.49849}}], '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'}}}}