UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009151 |
|---|---|
| Receipt number | R000010728 |
| Scientific Title | Study of therapeutic effect of esomeprazole on patients with gastroesophageal reflux disease associated with paroxysmal atrial fibrillation |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2015/06/03 19:34:25 |
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Basic information
Public title
Study of therapeutic effect of esomeprazole on patients with gastroesophageal reflux disease associated with paroxysmal atrial fibrillation
Acronym
Effect of esomeprazole on paroxysmal atrial fibrillation
Scientific Title
Study of therapeutic effect of esomeprazole on patients with gastroesophageal reflux disease associated with paroxysmal atrial fibrillation
Scientific Title:Acronym
Effect of esomeprazole on paroxysmal atrial fibrillation
Region
| Japan |
Condition
Condition
paroxysmal atrial fibrillation and gastroesophageal reflux disease
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of esomeprazole on paroxysmal atrial fibrillation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of F-scale scores by esomeprazole
Key secondary outcomes
Suppressive effect of esomeprazole on paroxysmal atrial fibrillation evaluated by Holter monitoring
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-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
pharmacological intervention
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
patients with paroxysmal atrial fibrillation (AF) and gastroesopageal reflux disease (GERD), i.e., AF paroxysms was so frequent as 2 - 3 times per month, and GERD was diagnozed as F-scale scores of 8 points or more.
Key exclusion criteria
patients with drug allergy for proton pump inhibitors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Maruyama, MD |
Organization
Kyushu University
Division name
Faculty of Arts and Science
Zip code
Address
Kasuga Kohen, 6-1, Kasuga 816-8580, Japan
TEL
+81-92-583-7685
maruyama@artsci.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Maruyama, MD. |
Organization
Kyushu University
Division name
Faculty of Arts and Science
Zip code
Address
Kasuga Kohen, 6-1, Kasuga 816-8580, Japan
TEL
+81-92-583-7685
Homepage URL
http://www.artsci.kyushu-u.ac.jp
maruyama@artsci.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
国立大学法人九州大学病院ハートセンター外来
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 30 | Day |
Other
Other related information
nothing particular
Management information
Registered date
| 2012 | Year | 10 | Month | 19 | Day |
Last modified on
| 2015 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010728
