UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008810
Receipt No. R000010356
Scientific Title Evaluation of preventive efficacy of Irsogladine maleate to stomatitis by Fluoropyrimidine anticancer agent.
Date of disclosure of the study information 2012/08/30
Last modified on 2013/07/26

* 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 Evaluation of preventive efficacy of Irsogladine maleate to stomatitis by Fluoropyrimidine anticancer agent.
Acronym Evaluation of preventive efficacy of Irsogladine maleate to stomatitis by Fluoropyrimidine anticancer agent.
Scientific Title Evaluation of preventive efficacy of Irsogladine maleate to stomatitis by Fluoropyrimidine anticancer agent.
Scientific Title:Acronym Evaluation of preventive efficacy of Irsogladine maleate to stomatitis by Fluoropyrimidine anticancer agent.
Region
Japan

Condition
Condition Stomatitis by anticancer agent.
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Use the Irsogladine maleate in patients with the administration of the fluoropyrimidine anticancer agent, to verify the efficacy and safety as an indicator subjective symptoms and associated stomatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stomatitis is more than Grade2 of CTCAE.
Occurrence of oral symptoms.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Irsogladine maleate (GaslonN OD Tablets)
Interventions/Control_2 No medication
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)Patients who use Fluoropyrimidine anticancer agent, and are more than 20 years old.
2)Patients who has symptoms to exacerbate gastric ulcer, acute gastritis and/or chronic gastritis.
3)Informed consent.
Key exclusion criteria 1)Patients with stomatitis and/or oral symptoms before the start of treatment.
2)Patients who are pregnant, suspected to be pregnant or breastfeeding.
3)Patients with drug allergy and/or history of severe side effect due to irsogladine maleate.
4)The patient who was considered ineligible by the investigators.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiko Hayashi
Organization Kanazawa Medical University
Division name Department of Gastroenterology
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-2211
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa Medical University
Division name Department of Gastroenterology
Zip code
Address
TEL 076-286-2211
Homepage URL
Email

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization Kanazawa Medical University
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
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
2012 Year 08 Month 30 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
2012 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 31 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
2012 Year 08 Month 30 Day
Last modified on
2013 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010356

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.