UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012434 |
|---|---|
| Receipt number | R000014548 |
| Scientific Title | The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD -multicenter randomized controlled study of irsogladine + PPI versus PPI alone- |
| Date of disclosure of the study information | 2013/11/28 |
| Last modified on | 2019/03/22 17:17:24 |
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Basic information
Public title
The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD
-multicenter randomized controlled study of irsogladine + PPI versus PPI alone-
Acronym
The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD
Scientific Title
The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD
-multicenter randomized controlled study of irsogladine + PPI versus PPI alone-
Scientific Title:Acronym
The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD
Region
| Japan |
Condition
Condition
gastric tumor(early gastric cancer, gastric adenoma)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the efficacy of combined therapy with irsogladine and PPI for the patients with early gastric cancer or gastric adenoma during treatment of antithrombotic drugs after ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Frequency of gastrointestinal bleeding after ESD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
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
rabeprazole 10mg/day p.o. for 8 weeks
Interventions/Control_2
rabeprazole 10mg/day and irsogladine 4mg/day p.o. for 8 weeks
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
Subjects with gastric tumor who are aged 20 years or older when the written informed consent is obtained
Key exclusion criteria
1)Subjects with hematemesis, melena or anemia lack of hemoglobin 2 g/dL or more during the observation period
2)Subjects with significant hepatic disease, renal disease, heart disease or respiratory disease
3)Subjects with a history of gastrointestinal surgery other than appendectomy
4)Subjects orally taking or planning to orally take drug other than rabeprazole or irsogladine
5)Pregnancy or lactation
6)Subjects whom otherwise the investigator determined ineligible as the subject
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Higuchi |
Organization
Osamka Medical Collage
Division name
Department of Internal Medicine
Zip code
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
072-683-1221
higuchi@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihisa Takeuchi |
Organization
Osaka Medical College Hospital
Division name
Endoscopic Center
Zip code
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
in2097@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 11 | Month | 28 | 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
| 2013 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 16 | 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 | 28 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014548
