UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012363 |
|---|---|
| Receipt number | R000014453 |
| Scientific Title | Study of the effectiveness of mosapride for GERD patients with sleep disorders |
| Date of disclosure of the study information | 2013/11/20 |
| Last modified on | 2020/05/26 12:12:11 |
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Basic information
Public title
Study of the effectiveness of mosapride for GERD patients with sleep disorders
Acronym
Study of the effectiveness of mosapride for GERD patients with sleep disorders
Scientific Title
Study of the effectiveness of mosapride for GERD patients with sleep disorders
Scientific Title:Acronym
Study of the effectiveness of mosapride for GERD patients with sleep disorders
Region
| Japan |
Condition
Condition
Gastroesophageal Reflux Disease
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For gastroesophageal reflux disease patients with sleep disorders despite the administration of a proton pump inhibitor, to the obvious add-on medication of mosapride whether or not effective in improving sleep disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre-dose, two weeks after dosing, four weeks after dosing, have them listed Japanese translation of the Quality of Life in Reflux and Dyspepsia (QOLRAD-J), Epworth Sleepness Scale (ESS), Pittsburgh Sleep Quality Index in (PSQI), respectively to evaluate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Proton pump inhibitor of the standard dose (+)
mosapride(15 mg / day for 4 weeks)
Interventions/Control_2
Proton pump inhibitor of the standard dose(+)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In GERD patients with sleeping disorders, who Proton pump inhibitor of standard doses of (PPI) during treatment
Key exclusion criteria
Example that started the oral sleep-inducing agent within two weeks.
Patients with serious underlying disease that affect sleep.
Examples are allergic to mosapride.
Examples of oral administration of the drug combination and attention mosapride.
Examples of oral medicine in the related to gastrointestinal motor function.
Patients with psychiatric disorders.
Examples of surgical procedures after the gastroesophageal.
Example pregnant or nursing.
Example not be obtained consent.
Example the attending physician is deemed inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eiko |
| Middle name | |
| Last name | Okimoto |
Organization
Shimane University School of Medicine
Division name
Department of Gastroenterology
Zip code
693-0021
Address
Izumo, Shimane Prefecture Enya-cho 89-1
TEL
0853-23-2111
okimotoeiko@outlook.com
Public contact
Name of contact person
| 1st name | Eiko |
| Middle name | |
| Last name | Okimoto |
Organization
Shimane University School of Medicine
Division name
Department of Gastroenterolog
Zip code
693-0021
Address
Izumo, Shimane Prefecture Enya-cho 89-1
TEL
0853-20-2190
Homepage URL
okimotoeiko@outlook.com
Sponsor or person
Institute
Department of Gastroenterology , Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology , Shimane University School of Medicine
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
Shimane University School of Medicine Clinical Research Center
Address
Izumo, Shimane Prefecture Enya-cho 89-1
Tel
:0853-20-2492
tiken@med.shimane-u.ac.jp
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
島根大学医学部付属病院（島根県）、出雲市立総合医療センター（島根県）、益田地域医療センター医師会病院（島根県）、松江市立病院（島根県）、松江赤十字病院（島根県）、はまもと内科クリニック（島根県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
URL releasing protocol
Number of participants that the trial has enrolled
0
Results
Discontinuation of the test
Results date posted
| 2020 | Year | 05 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Discontinuation of the test
Participant flow
Discontinuation of the test
Adverse events
Discontinuation of the test
Outcome measures
Discontinuation of the test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 20 | Day |
Last modified on
| 2020 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014453
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