Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-09 @ 7:50 AM
Study NCT ID:
NCT01788605
Status:
UNKNOWN
Last Update Posted:
2014-12-08
First Post:
2013-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C071315', 'term': 'ramosetron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-05', 'studyFirstSubmitDate': '2013-02-07', 'studyFirstSubmitQcDate': '2013-02-07', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the number of vomiting episodes', 'timeFrame': 'within 1 week after the end of conditioning regimen'}, {'measure': 'grade of nausea and need for rescue therapy', 'timeFrame': 'within 1 week after the end of conditioning regimen'}], 'primaryOutcomes': [{'measure': 'efficacy of ramosetron in terms of complete response (no emesis, no rescue therapy) during the conditioning regimen and within 3 or 6 days after the end of the conditioning regimen', 'timeFrame': 'within 1 week after the end of conditioning regimen'}], 'secondaryOutcomes': [{'measure': 'the efficacy of second dose of ramosetron for the treatment of breakthrough emesis', 'timeFrame': 'within 1 week after the end of conditioning regimen'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hematologic malignancies', 'hematopoietic stem cell transplantation', 'ramosetron', 'emesis'], 'conditions': ['Hematologic Malignancies']}, 'descriptionModule': {'briefSummary': '1. The purpose of this study is to determine the efficacy of ramosetron for the prevention of emesis and the control of nausea and vomiting despite of the prophylactic antiemetic treatment during hematopoietic stem cell transplantation\n2. The study hypothesis is that ramosetron is effective for the prevention of emesis and control of emesis and/or vomiting that develop after the prophylactic antiemetic therapy in the setting of hematopoietic stem cell transplantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing hematopoietic stem cell transplantation conditioned with highly or moderately emetogenic drugs or total body irradiation (TBI) for hematologic malignancies\n2. aged over 18 yrs\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2\n4. patients who are able to take oral medications\n5. patients who get well-informed and sign the consent\n\nExclusion Criteria:\n\n1. Patients complicating\n\n * severe hypertension (systolic blood pressure \\> 210 mmHg or diastolic blood pressure \\> 120 mmHg)\n * significant heart disease such as congestive heart failure\n * renal insufficiency (serum Cr \\>= 3.0 mg/dL)\n * liver disease (Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \\> 3 upper normal limit; alkaline phosphatase (ALP) \\> 2 upper normal limit)\n2. Patients complicated by conditions such as gastrointestinal obstruction or active peptic ulcer causing emesis\n3. Patients with brain tumor, brain metastasis and epilepsy\n4. Patients with the history of extrapyramidal symptom\n5. Patients with the history of allergy to serotonin antagonists\n6. pregnant or lactating women\n7. Patients with drug abuse or psychiatric illness, or patients who are not capable of the normal communications'}, 'identificationModule': {'nctId': 'NCT01788605', 'briefTitle': 'Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Prospective, Single-arm Phase 2 Trial to Evaluate Efficacy and Safety of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation for Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'CBMTC-supp001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ramosetron', 'interventionNames': ['Drug: ramosetron']}], 'interventions': [{'name': 'ramosetron', 'type': 'DRUG', 'armGroupLabels': ['ramosetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bo-Kyung Kim, RN', 'role': 'CONTACT', 'email': 'mikaella7@naver.com', 'phone': '82-50-7448-6371'}, {'name': 'Ki-Seong Eom, MD', 'role': 'CONTACT', 'email': 'dreom@catholic.ac.kr', 'phone': '82-2-2258-6056'}, {'name': 'Jong-Wook Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Catholic Blood & Marrow Transplantation Center, Seoul St Mary's Hospital, the Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ki-Seong Eom, MD', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}