UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008063 |
|---|---|
| Receipt number | 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 09:52:20 |
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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
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
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
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
daisuke@juntendo.ac.jp
Sponsor or person
Institute
University of Juntendo, Department of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009474
