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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name