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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008063
Receipt No. R000009474
Scientific Title Investigation of the treatment effect of Lansoprazole to sleep related GERD
Date of disclosure of the study information 2012/05/31
Last modified on 2012/05/31

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Basic information
Public title Investigation of the treatment effect of Lansoprazole to sleep related GERD
Acronym Investigation of the treatment effect of Lansoprazole to sleep related GERD
Scientific Title Investigation of the treatment effect of Lansoprazole to sleep related GERD
Scientific Title:Acronym Investigation of the treatment effect of Lansoprazole to sleep related GERD
Region
Japan

Condition
Condition sleep related gastroesophageal reflux disease
Classification by specialty
Medicine in general Gastroenterology Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The medical treatment in Lansoprazole to To investigate whether Lansoprazole effects not only GERD symptom but also the symptom of sleep related gastroesophageal reflux disease who is increasing in recent years
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes .Improvement of the Pittsburgh sleep quality index.
.Improvement of the Frequency Scale for the Symptoms of GERD
Key secondary outcomes .Various physical findings
.Various laboratory evidence
.upper gastrointestional endoscopy
.Health Related Quality of Life
.Epworth sleepiness Scale
.Beck Depression Inventory
.Reflux Finding Score
.pharyngeal obstruction

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 Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sleep disturbance(+)
Interventions/Control_2 sleep disturbance(-)
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

Not applicable
Gender Male and Female
Key inclusion criteria sleep related Gastroesophageal Reflux Disease patients
Key exclusion criteria .The patient who has an anamnesis of hypersensitivity to the ingredient of Lansoprazole
.The patient who cannot take this agent properly
.The patient who take atazanavir sulfate
.The patient in whom oral administration is impossible
.The patient with advanced respiratory-organs control
.The patient who has taken the sleep introduction agent
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Asaoka
Organization University of Juntendo
Division name Department of Gastroenterology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Juntendo
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email daisuke@juntendo.ac.jp

Sponsor
Institute University of Juntendo, Department of Gastroenterology
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 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
2012 Year 05 Month 31 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 Preinitiation
Date of protocol fixation
2012 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 06 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
2012 Year 05 Month 31 Day
Last modified on
2012 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009474


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