UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012223 |
|---|---|
| Receipt number | R000012179 |
| Scientific Title | Effect of esomeprazole 4-week use in reflux esophagitis patient with persistent symptoms |
| Date of disclosure of the study information | 2013/11/06 |
| Last modified on | 2018/03/07 15:17:27 |
* 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
Effect of esomeprazole 4-week use in reflux esophagitis patient with persistent symptoms
Acronym
Effect of esomeprazole in RE patient
Scientific Title
Effect of esomeprazole 4-week use in reflux esophagitis patient with persistent symptoms
Scientific Title:Acronym
Effect of esomeprazole in RE patient
Region
| Japan |
Condition
Condition
reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of esomeprazole (20mg) in RE patients with the use of GERDQ questionare
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Degree of satisfuctionion with GERDQ
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
esomeprazole 20mg
Interventions/Control_2
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. diagnosed as RE by endoscope examination
2. receiving H2RA/PPI for >4weeks
3. regarded as insufficient treatment by GERDQ questionnare
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Ito |
Organization
Hiroshima University Hospital
Division name
Gastroenterology and Metabolism
Zip code
Address
1-2-3 Kasumi, Minanmi-ku Hiroshima
TEL
082-257-5591
maito@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Ito |
Organization
Hiroshima University Hospital
Division name
Gastroenterology and Metabolism
Zip code
Address
1-2-3 Kasumi, Minanmi-ku Hiroshima
TEL
+81-82-57-5191
Homepage URL
maito@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Dept of Gastroenterology and Metabolism,Hiroshima University
Organization
Division
Category of Funding Organization
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 | 06 | 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
| 2013 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | 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
| 2013 | Year | 11 | Month | 06 | Day |
Last modified on
| 2018 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012179
