Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-04-22 @ 12:33 PM
Study NCT ID:
NCT02200666
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2014-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7793}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2014-07-24', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse event incidence', 'timeFrame': 'from baseline to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes mellitus', 'Diabetes', 'Forxiga', 'Long-term use'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3067&filename=JP_PMS%20Protocol_FXG_D1692C00014_E_Redacted.pdf', 'label': 'Redacted Protocol'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1692C00014&attachmentIdentifier=28022cf7-726c-4258-b5cc-d32639730783&fileName=CSR_synopsis_D1692C00014.pdf&versionIdentifier=', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga)\n\n* Development of ADRs specified as Key Investigation Items and the risk factors\n* Contributing factors possibly having an impact on the safety and efficacy\n* Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is the indication of the drug.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is the indication of the drug.\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT02200666', 'briefTitle': 'Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use', 'orgStudyIdInfo': {'id': 'D1692C00014'}}, 'contactsLocationsModule': {'locations': [{'zip': 'D1692C00014', 'city': 'Aichi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': 'D1692C00014', 'city': 'Akita', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': 'D1692C00014', 'city': 'Aomori', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 40.81667, 'lon': 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