- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01788605
Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation
December 5, 2014 updated by: Ki-Seong Eom, MD, The Catholic University of Korea
Prospective, Single-arm Phase 2 Trial to Evaluate Efficacy and Safety of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation for Hematologic Malignancies
- 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
- 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
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
65
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 137-701
- Recruiting
- Catholic Blood & Marrow Transplantation Center, Seoul St Mary's Hospital, the Catholic University of Korea
-
Contact:
- Bo-Kyung Kim, RN
- Phone Number: 82-50-7448-6371
- Email: mikaella7@naver.com
-
Contact:
- Ki-Seong Eom, MD
- Phone Number: 82-2-2258-6056
- Email: dreom@catholic.ac.kr
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Principal Investigator:
- Jong-Wook Lee, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing hematopoietic stem cell transplantation conditioned with highly or moderately emetogenic drugs or total body irradiation (TBI) for hematologic malignancies
- aged over 18 yrs
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- patients who are able to take oral medications
- patients who get well-informed and sign the consent
Exclusion Criteria:
Patients complicating
- 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)
- Patients complicated by conditions such as gastrointestinal obstruction or active peptic ulcer causing emesis
- Patients with brain tumor, brain metastasis and epilepsy
- Patients with the history of extrapyramidal symptom
- Patients with the history of allergy to serotonin antagonists
- pregnant or lactating women
- Patients with drug abuse or psychiatric illness, or patients who are not capable of the normal communications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ramosetron
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: within 1 week after the end of conditioning regimen
|
within 1 week after the end of conditioning regimen
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the efficacy of second dose of ramosetron for the treatment of breakthrough emesis
Time Frame: within 1 week after the end of conditioning regimen
|
within 1 week after the end of conditioning regimen
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the number of vomiting episodes
Time Frame: within 1 week after the end of conditioning regimen
|
within 1 week after the end of conditioning regimen
|
grade of nausea and need for rescue therapy
Time Frame: within 1 week after the end of conditioning regimen
|
within 1 week after the end of conditioning regimen
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Anticipated)
February 1, 2015
Study Registration Dates
First Submitted
February 7, 2013
First Submitted That Met QC Criteria
February 7, 2013
First Posted (Estimate)
February 11, 2013
Study Record Updates
Last Update Posted (Estimate)
December 8, 2014
Last Update Submitted That Met QC Criteria
December 5, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Hematologic Diseases
- Neoplasms
- Hematologic Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Serotonin Agents
- Serotonin Antagonists
- Ramosetron
Other Study ID Numbers
- CBMTC-supp001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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