UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014063 |
|---|---|
| Receipt number | R000016373 |
| Scientific Title | Effect of mosapride citrate on human gastric accommodation |
| Date of disclosure of the study information | 2014/05/26 |
| Last modified on | 2014/05/25 19:04:32 |
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Basic information
Public title
Effect of mosapride citrate on human gastric accommodation
Acronym
Effect of Mosapride on gastric accommodation
Scientific Title
Effect of mosapride citrate on human gastric accommodation
Scientific Title:Acronym
Effect of Mosapride on gastric accommodation
Region
| Japan |
Condition
Condition
Functional dyspepsia
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the hypothesis that mosapride enhances gastric accommodation in normal individuals
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We inserted a tube with a bag into human proximal stomach, and compared the bag volume before and after a meal.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Each subject performs experiments after administration of mosapride citrate.
Interventions/Control_2
Each subject performs experiments after administration of 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Subjects are healthy male indivisuals. None of the subjects have symptoms or a history of gastrointestinal disease or drug allergies, nor do they take any medication.
Key exclusion criteria
Subjects who have symptoms or a history of gastrointestinal disease or drug allergies, or who take any medication are excluded.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomofumi Amano |
Organization
National center of Neurology and Psychiatry
Division name
General medicine
Zip code
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
tamano@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomofumi Amano |
Organization
national center of Neurology and Psychiatry
Division name
General medicine
Zip code
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
tamano@ncnp.go.jp
Sponsor or person
Institute
National center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
国立精神・神経医療研究センター
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 26 | 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
Gastric accommodation, expressed as the difference between pre and postmeal intra-bag volumes, was significantly enhanced by mosapride (322.5 +- 29.6 mL) compared with placebo (150.8 +- 26.2 mL, P=0.0004)
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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 25 | Day |
Last modified on
| 2014 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016373
