UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003747 |
|---|---|
| Receipt number | R000004539 |
| Scientific Title | The open study for the effects of mosapride citrate on gastric ulcer healing after endoscopic submucosal disection. |
| Date of disclosure of the study information | 2010/06/14 |
| Last modified on | 2011/12/19 14:42:29 |
* 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
The open study for the effects of mosapride citrate on gastric ulcer healing after endoscopic submucosal disection.
Acronym
The effect of mosapride on ESD-induced gastric ulcer.
Scientific Title
The open study for the effects of mosapride citrate on gastric ulcer healing after endoscopic submucosal disection.
Scientific Title:Acronym
The effect of mosapride on ESD-induced gastric ulcer.
Region
| Japan |
Condition
Condition
gastric ulcer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of mosapride citrate on ulcer healing post endoscopic mucosal resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
gastric ulcer area
Key secondary outcomes
blood concentration of omeprazole
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Omeprazole 20mg once per day
1 month
Interventions/Control_2
Omeprazole 20mg once per day + Mosapride citrate 5mg 3 times per day
1 month
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women aged 20 or over,and under 80.
Patients received endoscopic submucosal disection for early gastric cancer.
Patients gave consent in writing.
Key exclusion criteria
Patients who had received gastrectomy.
Patients who have a history of a previous drug allergy.
Patients with serious comorbidities.
Patients considered inappropriate by the responsible doctor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology
Zip code
Address
465 Kajii-cho Kamigyo-ku, Kyoto, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Takagi |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology
Zip code
Address
465 Kajii-cho Kamigyo-ku, Kyoto, Japan
TEL
Homepage URL
Sponsor or person
Institute
Division of Gastroenterology, Kyoto Prefectural University of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Kyoto-fu Igaku Shinkou-kai
Organization
Division
Category of Funding Organization
Non profit foundation
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
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 14 | 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
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 13 | Day |
Last modified on
| 2011 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004539
