Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-04 @ 6:53 PM
Study NCT ID:
NCT03148704
Status:
UNKNOWN
Last Update Posted:
2017-05-11
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules (Ruo Shan®)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077924', 'term': 'Palonosetron'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-06-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2017-05-08', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using.", 'timeFrame': 'A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day', 'description': '1. Report the adverse effects of palonosetron hydrochloride capsules(Ruo Shan®) that we already known；\n2. Report if there is any new adverse effects；\n3. Report the incidence and the situation of the above adverse effects；\n4. Report the adverse effects in special groups, like pregnant women, children, elderly patients, and patients with liver and kidney dysfunction；\n5. Report other safety issues related to drug using method, drug packaging method and drug quality.'}], 'secondaryOutcomes': [{'measure': 'Report the efficacy of palonosetron hydrochloride capsules.', 'timeFrame': 'A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day', 'description': 'Report the control condition of nausea and vomiting.'}, {'measure': 'Report the widely used population characteristics.', 'timeFrame': 'A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day', 'description': "Report the patients' disease, age, treatment, and chemotherapy drugs."}, {'measure': 'Report the clinical using features of palonosetron hydrochloride capsules.', 'timeFrame': 'A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day', 'description': 'Report the Using does,time,and frequency of palonosetron hydrochloride capsules,and the concomitant drugs .'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Palonosetron']}, 'descriptionModule': {'briefSummary': "Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.", 'detailedDescription': "Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.\n\n1. Observe the adverse effects of palonosetron hydrochloride capsules(Ruo Shan®) that we already known, and whether there is any new adverse effects.Observe the incidence and the situation of adverse effects. Pay attention to the adverse effects in special groups, like pregnant women, children, elderly patients, and patients with liver and kidney dysfunction. Observe other safety issues related to drug using method, drug packaging method and drug quality.\n\n \\[Time Frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day\\]\n\n Secondary Outcome Measures:\n2. Furtherly clarify the efficacy of palonosetron hydrochloride capsules, and the widely used population characteristics, and clinical using features of palonosetron hydrochloride capsules.\n\n\\[Time Frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day\\]"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Use palonosetron hydrochloride capsules(Ruo Shan®) .Specific methods of using the drugs are not limited .\n* Elderly patients do not need to adjust the dosage of the drug.\n* Children using the drug and dose adjustment need to be evaluated by the doctor.\n* Pregnant and lactating patients using the drug need to be evaluated by the doctor.\n* 5-HT3RA allergic patients do not recommend the use of this drug.\n\nExclusion Criteria:\n\n* All situations that the doctor think it is not suitable to use palonosetron hydrochloride capsules(Ruo Shan®) .'}, 'identificationModule': {'nctId': 'NCT03148704', 'briefTitle': 'Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules (Ruo Shan®)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cttq'}, 'officialTitle': 'Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules', 'orgStudyIdInfo': {'id': 'Ruo Shan new drug monitoring'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'palonosetron palonosetron hydrochloride', 'description': 'A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)', 'interventionNames': ['Drug: palonosetron hydrochloride capsules']}], 'interventions': [{'name': 'palonosetron hydrochloride capsules', 'type': 'DRUG', 'otherNames': ['Ruo Shan®'], 'description': "Collect all the patients' safty and efficacy data as long as they use palonosetron hydrochloride capsules(Ruo Shan®) .Specific methods of using the drugs are not limited .", 'armGroupLabels': ['palonosetron palonosetron hydrochloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qin shukui', 'role': 'CONTACT'}], 'facility': 'The 81st Hostital of PLA', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'zheng bo', 'role': 'CONTACT', 'email': 'jtuu@163.com', 'phone': '18136659876'}], 'overallOfficials': [{'name': 'qin shu kui', 'role': 'STUDY_CHAIR', 'affiliation': 'The 81st Hostital of PLA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cttq', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}