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Recruitment status Completed
Unique ID issued by UMIN UMIN000011797
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email bk2m-cbi@asahi-net.or.jp

Sponsor
Institute Heiwadai clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013661


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