UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012295 |
|---|---|
| Receipt number | 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 | 2023/11/22 09:26:21 |
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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
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
tmnhdk@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine , University of Miyazaki Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
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
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014378
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