UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012144 |
|---|---|
| Receipt number | 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 14:29:06 |
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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
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
m2039002@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014178
