UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012363
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email okimotoeiko@outlook.com

Sponsor
Institute Department of Gastroenterology , Shimane University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014453

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.