UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008161 |
|---|---|
| Receipt number | R000009610 |
| Scientific Title | The study for the efficacy of the combine therapy with proton pump inhibitor and irsogladine for the post-endoscopic submucosal dissection (ESD) gastric ulcer |
| Date of disclosure of the study information | 2012/06/13 |
| Last modified on | 2023/12/27 17:29:22 |
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Basic information
Public title
The study for the efficacy of the combine therapy with proton pump inhibitor and irsogladine for the post-endoscopic submucosal dissection (ESD) gastric ulcer
Acronym
The combined therapy with proton pump inhibitor and irsogladine for post-ESD gastric ulcer
Scientific Title
The study for the efficacy of the combine therapy with proton pump inhibitor and irsogladine for the post-endoscopic submucosal dissection (ESD) gastric ulcer
Scientific Title:Acronym
The combined therapy with proton pump inhibitor and irsogladine for post-ESD gastric ulcer
Region
| Japan |
Condition
Condition
Gastric ulcer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of the combined therapy with proton pump inhibitor and irsogladine for the artificial gastric ulcer after endoscopic submucosal dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cure rates of gastric ulcer at 4 and 8 weeks of the treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rabeprazole 10mg/day for 8 weeks p.o.
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
Patients over the age of 20 with gastric adenoma or early cancer who were referred to our hospital for the purpose of ESD
Key exclusion criteria
1)Patients with repeated bleeding
2)major organ failure (such as cardiac and
pulmonary complications)
3)Those with drug allergy
4)Concomitant administration of anticoagulants and antiinflammatory
drugs
5)Patients with residual cancer histologically
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hidemi |
| Middle name | |
| Last name | Goto |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4668550
Address
65,Tsurumai-cho,Showa-ku,Nagoya
TEL
0527412111
myhr@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryoji |
| Middle name | |
| Last name | Miyahara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
65,Tsurumai-cho,Showa-ku,Nagoya 466-8560
TEL
09058771669
Homepage URL
ryoji.miyahara@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
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
Nagoya University Hospital Institutional review board
Address
65,Tsurumai-cho,Showa-ku,Nagoya 466-8560
Tel
052-741-2111
sentanjimu@med.nagoya-u.ac.jp
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 | 06 | Month | 13 | 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
40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009610
