Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone
NCT ID: NCT01536691
Last Updated: 2012-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
338 participants
INTERVENTIONAL
2011-06-30
2013-02-28
Brief Summary
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Prospective multicenter, randomized, single blinded, phase III study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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ramosetron, aprepitant, dexamethasone
ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
ramosetron
ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
ondansetron, aprepitant, dexamethasone
ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
ondansetron
ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
Interventions
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ramosetron
ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
ondansetron
ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status 0-2
3. Available oral administration of study drugs
4. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion Criteria
2. Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting
3. Patients who have nausea and vomiting within 1 week before chemotherapy
4. Patients who should take steroid, antiemetics, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir for the treatment of other diseases
5. Patients with brain tumor, brain metastasis or seizure
6. Patients receiving chemotherapy within 12 months before enrollment
7. Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy
8. Patients who have known allergy or severe side effect on study drugs
9. Pregnant or lactating women, or women who wish to become pregnant
10. Others whom the investigator judges inappropriate as subjects for this study
20 Years
ALL
No
Sponsors
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Korean Cancer Study Group
OTHER
Astellas Pharma Korea, Inc.
INDUSTRY
Hallym University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Sangwon Shin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Locations
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Hyo Jung Kim
Anyang-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ROAD
Identifier Type: -
Identifier Source: org_study_id
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