UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012728 |
|---|---|
| Receipt number | R000014869 |
| Scientific Title | Effect on improvement of dyspeptic symptoms after the medication of esomeprazole |
| Date of disclosure of the study information | 2013/12/30 |
| Last modified on | 2015/06/12 13:45:10 |
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Basic information
Public title
Effect on improvement of dyspeptic symptoms after the medication of esomeprazole
Acronym
Effect on dyspeptic symptoms after the medication of esomeprazole
Scientific Title
Effect on improvement of dyspeptic symptoms after the medication of esomeprazole
Scientific Title:Acronym
Effect on dyspeptic symptoms after the medication of esomeprazole
Region
| Japan |
Condition
Condition
The patient who has taken 10 mg of rabeprazole four weeks or more
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate the efficacy of 20 mg esomeprazole on dyspeptic symptoms in paients with taking 10 mg of rabeprazole four weeks or more.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement rate of an upper abdomen symptom four or 6 weeks after medication of 20 mg esomeprazole.
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient who has taken 10 mg of rabeprazole four weeks or more
Key exclusion criteria
Allergy to esomeprazole
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori FUJIMURA |
Organization
The Sakakibara Heart Institute of Okayama
Division name
Gastroenterology
Zip code
Address
2-5-1, Nakai, Kita-ku, Okayama
TEL
086-225-7111
y.fujimura@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori FUJIMURA |
Organization
The Sakakibara Heart Institute of Okayama
Division name
Gastroenterology
Zip code
Address
2-5-1, Nakai, Kita-ku, Okayama
TEL
086-225-7111
Homepage URL
y.fujimura@me.com
Sponsor or person
Institute
Yoshinori FUJIMURA
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 | 12 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 30 | Day |
Last modified on
| 2015 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014869
