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

Phase 2

• Conditions: Hematologic Malignancies
• Interventions: Drug: ramosetron

• Registration Number: NCT01788605
• Lead Sponsor: The Catholic University of Korea

Brief Summary

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. 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

Not available

Study Timeline

• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Study Start: 2014-08
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Patients undergoing hematopoietic stem cell transplantation conditioned with highly or moderately emetogenic drugs or total body irradiation (TBI) for hematologic malignancies
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

1. 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)

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ramosetron	ramosetron	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
the efficacy of second dose of ramosetron for the treatment of breakthrough emesis	within 1 week after the end of conditioning regimen

Trial Locations

Locations (1)

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