Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-28 @ 10:23 AM
Study NCT ID:
NCT06887959
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2025-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Selected Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) for Pain Control at the End of Treatment', 'timeFrame': 'From Day 3 up to Day 14'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness, safety, and tolerability of SUZ for acute pain after laparoscopic procedures of the intraperitoneal or retroperitoneal cavities or arthroscopic orthopedic procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than or equal to (≤) 40.0 kilogram per meter square (kg/m\\^2)\n* Scheduled to undergo a procedure that is in one of the following categories that would typically be treated with opioid therapy for at least 72 hours postoperatively such as\n\n * Laparoscopic intraperitoneal or retroperitoneal procedure\n * Arthroscopic orthopedic procedure\n\nKey Exclusion Criteria:\n\n-Participated in previous study with Suzetrigine or received Journavx\n\nOther protocol defined Inclusion/Exclusion criteria will apply.'}, 'identificationModule': {'nctId': 'NCT06887959', 'briefTitle': 'A Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Selected Surgeries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Laparoscopic Procedures of the Intraperitoneal or Retroperitoneal Cavities or Arthroscopic Orthopedic Procedures', 'orgStudyIdInfo': {'id': 'VX24-548-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suzetrigine (SUZ)', 'description': 'Participants will receive SUZ for 14 days or until their pain resolves, whichever occurs first.', 'interventionNames': ['Drug: Suzetrigine']}], 'interventions': [{'name': 'Suzetrigine', 'type': 'DRUG', 'otherNames': ['VX-548', 'SUZ', 'Journavx'], 'description': 'Tablets for oral administration.', 'armGroupLabels': ['Suzetrigine (SUZ)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Clinical Trials', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Woodland International Research Group', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Gulfcoast Research Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Oasis Clinical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University HealthCare (CUH)', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital - Anesthesiology', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina - Hip & Knee Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Eximia Research-Durham', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital - Anesthesiology', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'West Clinical Research', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '28412', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Seaside Clinical Research Institute', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH Cleveland Medical Center - Anesthesiology', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Medical Center - Anethesiology', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'HD Research LLC | First Surgical Hospital', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '77043', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Village', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Tidewater Clinical Research', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}