UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008810 |
|---|---|
| Receipt number | 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 13:22:54 |
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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
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
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010356
