Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT00212602
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ONO-7436 Phase II Study in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D009325', 'term': 'Nausea'}], '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': 'D000077608', 'term': 'Aprepitant'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient proportion of complete response (no vomiting and no rescue treatment).'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with no vomiting, no rescue treatment, and no nausea (in each category or combination), frequency of vomiting, and time to first vomiting, and first rescue treatment.'}]}, 'conditionsModule': {'keywords': ['ONO-7436, Aprepitant, Vomiting, Nausea'], 'conditions': ['Malignant Tumor']}, 'referencesModule': {'references': [{'pmid': '20718754', 'type': 'DERIVED', 'citation': 'Takahashi T, Hoshi E, Takagi M, Katsumata N, Kawahara M, Eguchi K. Multicenter, phase II, placebo-controlled, double-blind, randomized study of aprepitant in Japanese patients receiving high-dose cisplatin. Cancer Sci. 2010 Nov;101(11):2455-61. doi: 10.1111/j.1349-7006.2010.01689.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients age 20 years or older\n2. Patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70 mg/m2 or more in under 3 hours\n3. Patients whose performance status is 0 to 2\n4. Other inclusion criteria as specified in the study protocol\n\nExclusion Criteria:\n\n1. In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin\n2. Patients who had vomiting or dry vomiting within 24 hours before the initial administration of the moderate or severe emetic chemotherapy (including cisplatin) on Day 1 of the study\n3. Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception\n4. Other exclusion criteria as specified in the study protocol'}, 'identificationModule': {'nctId': 'NCT00212602', 'briefTitle': 'ONO-7436 Phase II Study in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'ONO-7436 Phase II Study - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of ONO-7436 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Japan', 'orgStudyIdInfo': {'id': 'ONO-7436-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ONO-7436', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan', 'facility': 'Chugoku Region Facility'}, {'city': 'Chūbu', 'country': 'Japan', 'facility': 'Chubu Region Facility', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Region Facility'}, {'city': 'Hokuriku', 'country': 'Japan', 'facility': 'Hokuriku Region Facility'}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Kanto Region Facility'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Kinki Region Facility'}, {'city': 'Kyushu', 'country': 'Japan', 'facility': 'Kyushu Region Facility'}, {'city': 'Shikoku', 'country': 'Japan', 'facility': 'Shikoku Region Facility'}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Tohoku Region Facility', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Project Leader, Development Planning', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}