Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation
NCT ID: NCT01788605
Last Updated: 2014-12-08
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
PHASE2
65 participants
INTERVENTIONAL
2014-08-31
2015-02-28
Brief Summary
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2. 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
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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ramosetron
ramosetron
Interventions
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ramosetron
Eligibility Criteria
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Inclusion Criteria
2. aged over 18 yrs
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
4. patients who are able to take oral medications
5. patients who get well-informed and sign the consent
Exclusion Criteria
* severe hypertension (systolic blood pressure \> 210 mmHg or diastolic blood pressure \> 120 mmHg)
* significant heart disease such as congestive heart failure
* renal insufficiency (serum Cr \>= 3.0 mg/dL)
* liver disease (Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3 upper normal limit; alkaline phosphatase (ALP) \> 2 upper normal limit)
2. Patients complicated by conditions such as gastrointestinal obstruction or active peptic ulcer causing emesis
3. Patients with brain tumor, brain metastasis and epilepsy
4. Patients with the history of extrapyramidal symptom
5. Patients with the history of allergy to serotonin antagonists
6. pregnant or lactating women
7. Patients with drug abuse or psychiatric illness, or patients who are not capable of the normal communications
18 Years
ALL
No
Sponsors
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The Catholic University of Korea
OTHER
Responsible Party
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Ki-Seong Eom, MD
Associate Professor
Locations
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Catholic Blood & Marrow Transplantation Center, Seoul St Mary's Hospital, the Catholic University of Korea
Seoul, , South Korea
Countries
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Facility Contacts
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Bo-Kyung Kim, RN
Role: primary
Ki-Seong Eom, MD
Role: backup
Other Identifiers
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CBMTC-supp001
Identifier Type: -
Identifier Source: org_study_id