UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000984 |
|---|---|
| Receipt number | R000001184 |
| Scientific Title | A double-blind randomized controlled trial comparing 3mg and 1mg of ranisetron for the control of chemotherapy-induced acute emesis |
| Date of disclosure of the study information | 2008/01/19 |
| Last modified on | 2010/03/26 18:51:06 |
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Basic information
Public title
A double-blind randomized controlled trial comparing 3mg and 1mg of ranisetron for the control of chemotherapy-induced acute emesis
Acronym
Randomized controlled trial of granisetron for the prophylaxis of chemotherapy-induced emesis
Scientific Title
A double-blind randomized controlled trial comparing 3mg and 1mg of ranisetron for the control of chemotherapy-induced acute emesis
Scientific Title:Acronym
Randomized controlled trial of granisetron for the prophylaxis of chemotherapy-induced emesis
Region
| Japan |
Condition
Condition
Malignant tumor (breast cancer, lung cancer, gastric cancer, esophagus cancer, colorectal cancer, etc)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify that noninferiority of 1mg of granisetron to 3mg of granisetron in the prevention of chemotherapy-induced acute emesis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
complete protection from vomiting within 24 hours
Key secondary outcomes
1) Degree of nausea within 24 hours
2) Time to vomiting expression within 24 hours
3)The number of vomiting
4)Degree of nausea in the delayed phase
5)The change of the stool frequency
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Granisetron 3mg + dexamethasone
(drip infusion)
Interventions/Control_2
Granisetron 1mg + dexamethasone
(drip infusion)
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)Malignant tumor patients except for hematopoietic malignancy
(2)20 years-old over
(3)patients who receive the chemotherapy of the first course of each regimens
(4)patients who use highly emetogenic antineoplastic agents more than moderate risk category
<cf. ASCO clinical practice guideline,Recommendations for the use of Antiemetics>
(5)patients who have adequate organ functions
<Each of the following values are examined within 2weeks before registration for this study>
1)ALT <= 100 IU/L
2)AST <= 100 IU/L
3)T-Bil <= 2.0 mg/dL
4)CRE <= 1.5 mg/dL
(6)Written informed consent
Key exclusion criteria
(1)patients with history of hypersensitivity to 5-HT3 receptor antagonist and corticosteroids
(2)patient who do not have enough whole body state to the antineoplastic agents treatment
(3)pregnant or expecting woman
(4)patient who enforces radiotherapy in the abdomen on the day of chemotherapy
(5)uncontrollable diabetes mellitus
(6)hepatitis B or C virus Carrier
(7)patients having a clear vomiting symptom such as brain metastasis or obstruction to the passage of foods
(8)the patient who judged inappropriate as an object of this study
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kim Yong-Il |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of breast surgery Seirei Hamamatsu General Hospit
Zip code
Address
2-12-12 Sumiyoshi ,Hamamatsu,Shizuoka, 430-8558,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuji Daiki |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Pharmacy Seirei Hamamatsu General Hospit
Zip code
Address
2-12-12 Sumiyoshi ,Hamamatsu,Shizuoka, 430-8558,Japan
TEL
Homepage URL
Sponsor or person
Institute
Pharma Valley Center, Shizuoka Organization for Creation
Industries
Institute
Department
Personal name
Funding Source
Organization
Pharma Valley Center, Shizuoka Organization for Creation
Industries
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 01 | Month | 19 | 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
Completed
Date of protocol fixation
| 2007 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2009 | Year | 04 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 17 | Day |
Last modified on
| 2010 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001184
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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