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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012295
Receipt No. R000014378
Scientific Title A randomized comparative phase 2 study : Palonosetron single-dose vousus repeated-dose for prevention of nausea and vomiting induced by multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies .
Date of disclosure of the study information 2013/11/15
Last modified on 2020/05/25

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Basic information
Public title A randomized comparative phase 2 study : Palonosetron single-dose vousus repeated-dose for prevention of nausea and vomiting induced by multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies .
Acronym A randomized comparative phase 2 study : Palonosetron single-dose vousus repeated-dose for prevention of nausea and vomiting induced by multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies .
Scientific Title A randomized comparative phase 2 study : Palonosetron single-dose vousus repeated-dose for prevention of nausea and vomiting induced by multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies .
Scientific Title:Acronym A randomized comparative phase 2 study : Palonosetron single-dose vousus repeated-dose for prevention of nausea and vomiting induced by multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies .
Region
Japan

Condition
Condition haematological malignancies
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate the efficacy and safety of palonosetron repeated-dose (day1,3) compared with single-dose (day1) for prevention of nausea and vomiting induced by multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes CC (Complete Control) rate in overall phase ( 0-168 hours after chemotherapy ).
Key secondary outcomes CR (Complete Response)rate in overall phase (0-168 hours after chemotherapy ) and safety.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Palonosetron (0.75mg) intravenously dose 30 min before chemotherapy initiation on day1 . Palonosetron is administered on day 1 in the single-dose group.
Interventions/Control_2 Palonosetron (0.75mg) intravenously dose 30 min before chemotherapy initiation on day1.Palonosetron is administered on day1 and day3 in the repeated-dose group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Age 20=<
2. Haematological malignancies
3. Multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies.
4. Sufficient function of important organs
5. ECOG Performance Status of 0 to 2
6. Expected more than 1 months survival
7. Acquisition of written informed consent
Key exclusion criteria 1. Having complications (the intestinal tract paralysis, pulmonary fibrosis, diabetes, heart failure, myocardial infarction, angina, renal insufficiency, liver failure, mental disease, cerebrovascular disorder, active stomach, duodenal ulcer)
2. History of the severe hypersensitivity
3. A pregnant woman, a nursing girl .the man or woman who does not agree preventing conception during a study period .
4. History of the dosage of palonosetron
5. Not to have ability to cooperate about the procedure of this study or intention toward
6. Those judged to be not suitable by the attending physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kazuya
Middle name
Last name Shimoda
Organization Department of Internal Medicine , Faculty of Medicine , University of Miyazaki
Division name Division of Gastroenterology and Hematology
Zip code 889-1692
Address 5200 Kihara , Kiyotake , miyazaki 889-1692
TEL 0985-85-9121
Email tmnhdk@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name Tomonori
Middle name
Last name Hidaka
Organization Faculty of Medicine , University of Miyazaki Hospital
Division name Oncology unit
Zip code 889-1692
Address 5200 Kihara , Kiyotake , miyazaki 889-1692
TEL 0985-85-9121
Homepage URL
Email tmnhdk@med.miyazaki-u.ac.jp

Sponsor
Institute Faculty of Medicine , University of Miyazaki Hospital
Institute
Department

Funding Source
Organization Faculty of Medicine , University of Miyazaki Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Miyazaki Hospital, Clinical Research Support Center
Address 5200 Kihara , Kiyotake , miyazaki 889-1692
Tel 0985-85-1510
Email rinken@med.miyazaki-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 14 Day
Last modified on
2020 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014378

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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