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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009151
Receipt No. 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

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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
Email 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
Email maruyama@artsci.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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