UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011797 |
|---|---|
| Receipt number | R000013661 |
| Scientific Title | A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2013/09/18 19:36:11 |
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Basic information
Public title
A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease
Acronym
A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease
Scientific Title
A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease
Scientific Title:Acronym
A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with GERD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Change rate of average numerical rating scale (NRS) of sleep quality between a pre-dose and a post-dose of 2-4 weeks after administration
2)Fluctuation of scores in sleep dysfunction questionnaires between a pre-dose and a post-dose of 2-4 weeks after administration
Key secondary outcomes
Fluctuation of scores in F-scale questionnaires between a pre-dose and a post-dose of 2-4 weeks after administration
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
10 mg of sodium rabeprazole administered orally once daily from 2 to 4 weeks
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
A patient is eligible for the study if all of the following criteria are met:
1) Age 20 years or older
2) Patients with more than 8 scores in the Frequency scale for Symptoms of GERD (F-scale questionnaires)
3) Patient with at least 2 weeks washout period from the previous treatment by Proton pump inhibitors and Histamine H2-receptor antagonists
Key exclusion criteria
A patient is excluded from the study if any of the following criteria are met:
1) Patients with a history of hypersensitivity to any ingredients of sodium rabeprazole
2) Patients taking atazanavir sulfate or rilpivirine hydrochloride
3) Patients with serious hepatic function disorder
4) Elderly patients (Age 80 years and older)
5) Patients who were judged to be inappropriate for participation in this study by the investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyasu chibai |
Organization
Heiwadai clinic
Division name
Surgery
Zip code
Address
4-26-8,Heiwadai,Nerima-ku,Tokyo,Japan
TEL
03-5922-1241
bk2m-cbi@asahi-net.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoyasu chibai |
Organization
Heiwadai clinic
Division name
Surgery
Zip code
Address
4-26-8,Heiwadai,Nerima-ku,Tokyo,Japan
TEL
03-5922-1241
Homepage URL
bk2m-cbi@asahi-net.or.jp
Sponsor or person
Institute
Heiwadai clinic
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 | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The results was presented in the 85th meeting of Japan gastroenterological endoscopy society.
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 | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 17 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2013 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013661
