UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012691
Receipt number R000014831
Scientific Title Effect of gastric emptying of lubiprostone: a double-blind, crossover study by 13C breath test
Date of disclosure of the study information 2014/12/27
Last modified on 2014/01/16 16:26:11

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Basic information

Public title

Effect of gastric emptying of lubiprostone: a double-blind, crossover study by 13C breath test

Acronym

Effect of gastric emptying of lubiprostone

Scientific Title

Effect of gastric emptying of lubiprostone: a double-blind, crossover study by 13C breath test

Scientific Title:Acronym

Effect of gastric emptying of lubiprostone

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Lubiprostone, a selective activator of type 2 chloride channels, is approved for treatment of chronic idiopathic constipation and recently constipation-predominant irritable bowel syndrome. It has been suggested that lubiprostone has a prokinetic effect.
We study that effect of gastric emptying of lubiprostone by 13C breath test.

Basic objectives2

Others

Basic objectives -Others

gastric emptying time

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

gastric emptying time

Key secondary outcomes

symptom


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The group who takes lubiprostone 24µg

Interventions/Control_2

The group who takes 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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient who fills everything the following
1) Patient of 20 years or more
2) Patient who gives written informed consent

Key exclusion criteria

The patient who collides with either the following assumes that it dosen't put it in to the examination
1)Drug allergy
2)Subjects with malignancy
3)Others

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiko Inamori

Organization

Yokohama City University Hospital

Division name

Office of postgraduate medical education

Zip code


Address

3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan

TEL

+81-45-787-2800

Email

inamorim@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiko Inamori

Organization

Yokohama City University Hospital

Division name

Office of postgraduate medical education

Zip code


Address

3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan

TEL

+81-45-787-2800

Homepage URL


Email

inamorim@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Office of postgraduate medical education, Yokohama City University Hospital

Institute

Department

Personal name



Funding Source

Organization

ABBOTT JAPAN CO. LTD.

Organization

Division

Category of Funding Organization

Profit organization

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

横浜市立大学附属病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 27 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

Open public recruiting

Date of protocol fixation

2013 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 25 Day

Last modified on

2014 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014831


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name