Efficacy Study of Ramosetron in the Setting of Hematopoie... | NCT01788605

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

NCT01788605

Sponsor

The Catholic University of Korea

Status

Unknown status

Last Update Posted

Dec 8, 2014Estimated

Enrollment

65Estimated

Phase

Phase 2

Conditions

Hematologic Malignancies

Interventions

ramosetron

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Feb 2015Estimated

First Submitted Date

Feb 7, 2013

First Submission Date that Met QC Criteria

Feb 7, 2013

First Posted Date

Feb 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2014

Last Update Posted Date

Dec 8, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Label	Type	Description	Intervention Names
ramosetron	Experimental		Drug: ramosetron

Name	Type	Description	Arm Group Labels	Other Names
ramosetron	Drug		ramosetron

Outcomes Module

Primary Outcomes

Measure	Description	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		within 1 week after the end of conditioning regimen

Secondary Outcomes

Measure	Description	Time Frame
the efficacy of second dose of ramosetron for the treatment of breakthrough emesis		within 1 week after the end of conditioning regimen

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019337	Hematologic Neoplasms
D014839	Vomiting

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases