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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012144
Receipt No. R000014178
Scientific Title Effect of twice daily rabeprazole treatment on sleep disturbances in GERD patients with once daily PPI
Date of disclosure of the study information 2013/10/28
Last modified on 2013/10/28

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Basic information
Public title Effect of twice daily rabeprazole treatment on sleep disturbances in GERD patients with once daily PPI
Acronym Effect of PPI on sleep disturbances in patients with GERD
Scientific Title Effect of twice daily rabeprazole treatment on sleep disturbances in GERD patients with once daily PPI
Scientific Title:Acronym Effect of PPI on sleep disturbances in patients with GERD
Region
Japan

Condition
Condition gastroesophageal reflux disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we examine the effect of PPI on sleep disturbances in patients with GERD by using actigraph and electroencephalograph(EEG).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes parameters by actigraph
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rabeprazole sodium (10mg)
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
100 years-old >=
Gender Male and Female
Key inclusion criteria A diagnosis of erosive GERD including gradeM was made by the endoscopic examination before the PPI dosage start.
The patient who takes a rabeprazole sodium 10mg in the morning after the diagnose of GERD.
Patient having less than 95% of % SLEEP by actigraph.
Key exclusion criteria They were pregnant or nursing mother, or used atazanavir sulfate, or had allergy to rabeprazole sodium, Zollinger-Ellison syndrome and peptic ulcer disease.
Disease-related exclusion criteria included the following: severe disease of any major body system; malignant disease of any kind; gastrointestinal diseases such as esophageal stricture, primary esophagus motor disorders, systemic sclerosis, severe sleep disorder, depression or any other psychiatric disease associated with worsened QOL, past history of upper gastrointestinal surgery.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Fujiwara
Organization Osaka City University Graduate School of Medicine
Division name Osaka City University Graduate School of Medicine
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku,Osaka 545- 8585, Japan
TEL 06-6645-3811
Email yasu@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Hiramoto
Organization Osaka City University Graduate School of Medicine
Division name Osaka City University Graduate School of Medicine
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku,Osaka 545- 8585, Japan
TEL 06-6645-3811
Homepage URL
Email m2039002@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Hospital
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 28 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 Enrolling by invitation
Date of protocol fixation
2013 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 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 10 Month 28 Day
Last modified on
2013 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014178

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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