UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003626 |
|---|---|
| Receipt number | R000004398 |
| Scientific Title | Study investigating the prevalence of primary insomnia responsive to proton pump inhibitor treatment |
| Date of disclosure of the study information | 2010/05/24 |
| Last modified on | 2010/05/17 16:58:54 |
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Basic information
Public title
Study investigating the prevalence of primary insomnia responsive to proton pump inhibitor treatment
Acronym
proton pump inhibitor treatment for primary insomnia
Scientific Title
Study investigating the prevalence of primary insomnia responsive to proton pump inhibitor treatment
Scientific Title:Acronym
proton pump inhibitor treatment for primary insomnia
Region
| Japan |
Condition
Condition
primary insomnia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the number of cases with insomnia who are responsive to PPI treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Canges of QOLRAD-J, ESS, PSQI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 20mg/day omeprazole
Interventions/Control_2
placebo
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who need administration of a sleeping medicine for the treatment of insomnia.
Key exclusion criteria
Usage of a sleeping medicine in 2 weeks.
Cases treated as mental illness.
Usage of PPI or H2RA in 2 weeks.
With diseases that may influence sleep.
Pregnant or lactating women.
With allergy to omeprazole etc.
Others which attending doctors decide not suitable.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University
Division name
School of Medicine
Zip code
Address
89-1, Enya-cho, Izumo
TEL
0853-20-2190
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University
Division name
executive department
Zip code
Address
TEL
Homepage URL
ishikazu@jn.shimane-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Shimane University School of Medicine
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 05 | Month | 24 | 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
| 2010 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 17 | Day |
Last modified on
| 2010 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004398
