UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000304
Receipt No. R000000392
Scientific Title Randomized controlled trial of two intravenous doses of granisetron (1mg vs 3mg) for the prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients
Date of disclosure of the study information 2006/01/11
Last modified on 2012/10/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized controlled trial of two intravenous doses of granisetron (1mg vs 3mg) for the prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients
Acronym Randomized controlled trial of granisetron for the prophylaxis of chemotherapy-induced nausea and vomiting
Scientific Title Randomized controlled trial of two intravenous doses of granisetron (1mg vs 3mg) for the prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients
Scientific Title:Acronym Randomized controlled trial of granisetron for the prophylaxis of chemotherapy-induced nausea and vomiting
Region
Japan

Condition
Condition breast cancer , ovarian cancer , cervical cancer , endometrial cancer , etc
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examine Non-inferiority of 1mg of granisetron to 3mg of granisetron in the efficacy for chemotherapy-induced nausea and vomiting
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Complete Response
Key secondary outcomes Complete control

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Granisetron 1mg/body (drip on intravenous,day1)
Interventions/Control_2 Granisetron 3mg/body (drip on intravenous,day1)
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)20 years-old over
(2)PS (Eastern Cooperative Oncology Group performance status scale) 0-2
(3)patients to use the neoplastic agents belong to the acute emetic High risk category <refer to the ASCO clinical practice guideline,Recommendations for the use of Antiemetics>
(4)Each of the following values are examined within 3weeks before registration for this study
1)ANC>=1,000/mm2
2)GPT(ALT) <100IU/L
3)CRE<=1.5 (CBDCA:CRE<=2.5)
(5)Written informed consent
Key exclusion criteria (1)patients with known hypersensitivity to 5-HT3 receptor antagonist
(2)patients to use the neoplastic agents belong to the acute emetic category intermediate and High risk or to do the radiation therapy between Day2 and 7
(3)serious complications excepting malignancy (e.g. bowel obdormition, fibroid lung, cerebrovascular accident, active gastric and duodenum)
(4)can't exactly record episodes in diaries, Shoujyou-nisshi
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taisuke Hojo , Ph.D
Organization National Cancer Center Hospital
Division name Pharmacy Division
Zip code
Address 5-1-1 Tsukiji,Chuuou-ku,Tokyo,104-0045,Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahito Yonemura
Organization Granisetorn coordinating office
Division name Pharmacy Division of National Cancer Center Hospital
Zip code
Address 5-1-1 Tsukiji,Chuuou-ku,Tokyo,104-0045,Japan
TEL 03-3542-2511
Homepage URL
Email myonemur@ncc.go.jp

Sponsor
Institute Pharmacy Division of National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2006 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

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
2005 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2006 Year 11 Month 01 Day
Date of closure to data entry
2007 Year 03 Month 01 Day
Date trial data considered complete
2007 Year 03 Month 01 Day
Date analysis concluded
2007 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 01 Month 11 Day
Last modified on
2012 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000392

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.