Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation

NCT01788605 | Unknown Phase 2

• 1 other identifier: CBMTC-supp001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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
2. 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

Conditions

Hematologic Malignancies

Keywords

hematologic malignancies; hematopoietic stem cell transplantation; ramosetron; emesis

Outcome Measures

Primary Outcomes (1)

• 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

  within 1 week after the end of conditioning regimen

Secondary Outcomes (1)

• the efficacy of second dose of ramosetron for the treatment of breakthrough emesis

  within 1 week after the end of conditioning regimen

Other Outcomes (2)

• the number of vomiting episodes

  within 1 week after the end of conditioning regimen

• grade of nausea and need for rescue therapy

  within 1 week after the end of conditioning regimen

Study Arms (1)

ramosetron

EXPERIMENTAL

Drug: ramosetron

Interventions

ramosetron DRUG

ramosetron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Catholic Blood & Marrow Transplantation Center, Seoul St Mary's Hospital, the Catholic University of Korea

Seoul, 137-701, South Korea

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Vomiting

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: August 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

KR (1)