Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-25 @ 3:08 PM
Study NCT ID:
NCT00273468
Status:
COMPLETED
Last Update Posted:
2024-06-17
First Post:
2006-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017829', 'term': 'Granisetron'}], 'ancestors': [{'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 630}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2006-01-06', 'studyFirstSubmitQcDate': '2006-01-06', 'lastUpdatePostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients achieving Complete Control of CINV from the first administration until 24 h after the last administration of the moderately or highly emetogenic chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Times from start of chemotherapy to treatment failure for complete control (CC) and complete response (CR)'}, {'measure': 'Time from start of chemotherapy to first administration of rescue medication'}, {'measure': 'Time from start of chemotherapy to first emetic episode (vomiting/retching)'}, {'measure': 'Percentage of patients achieving CC and CR of CINV during different time periods'}, {'measure': 'Adverse events collected until 14 days after patch removal'}, {'measure': 'Patch adhesion'}]}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '20835873', 'type': 'DERIVED', 'citation': 'Boccia RV, Gordan LN, Clark G, Howell JD, Grunberg SM; Sancuso Study Group. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Support Care Cancer. 2011 Oct;19(10):1609-17. doi: 10.1007/s00520-010-0990-y. Epub 2010 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced Nausea and Vomiting (CINV)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be of non-childbearing potential and female patients must have a negative pregnancy test at the Screening Visit\n* Histologically and/or cytologically confirmed cancer with ECOG ≤2\n* Life expectancy of ≥ 3 months\n* Assigned to receive the first cycle of a new multi-day chemotherapy regimen including the daily administration of cytotoxic agent(s) with the emetogenic potential of level 3-5 (Hesketh Classification) on 3-5 days\n\nExclusion Criteria:\n\n* Hypersensitivity to adhesive plasters\n* Contraindications to 5-HT3 receptor antagonists\n* Clinically relevant abnormal laboratory values or hepatic, renal, infectious, neurological or psychiatric disorders or any other major systemic illness at the discretion of the Investigator\n* Any cause for nausea and vomiting other than CINV\n* Clinically relevant abnormal ECG parameters\n* Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study\n* A patient taking a medication to control the symptoms of a brain tumour, brain metastasis or seizure disorder'}, 'identificationModule': {'nctId': 'NCT00273468', 'briefTitle': 'To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Randomised, Active Control, Double-blind, Double-dummy, Parallel-group, Multi-national Study to Assess the Efficacy, Tolerability and Safety of the Granisetron Transdermal Delivery System in Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Moderately or Highly Emetogenic Multi-day Chemotherapy', 'orgStudyIdInfo': {'id': '392MD/15/C'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Granisetron', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}}}}