UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010965
Receipt number R000012833
Scientific Title Comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy
Date of disclosure of the study information 2013/07/26
Last modified on 2018/06/18 12:42:41

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Basic information

Public title

Comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy

Acronym

Comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy

Scientific Title

Comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy

Scientific Title:Acronym

Comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy

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 comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

gastric and small-bowel transit time

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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The group who takes Lubiprostone

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

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 doesn't put it in to the examination
1) Drug allergy
2) Subjects with malignancy
3)Others

Target sample size

6


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Nakajima

Organization

Yokohama City University Graduate School of Medicine

Division name

Gastroenterology Division

Zip code


Address

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

TEL

045-787-2640

Email

nakajima-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiko Inamori

Organization

Yokohama City University Graduate School of Medicine

Division name

Gastroenterology Division

Zip code


Address

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

TEL

045-787-2640

Homepage URL


Email

inamorim@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Gastroenterology Division, Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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


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



Other administrative information

Date of disclosure of the study information

2013 Year 07 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


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 07 Month 26 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 06 Month 14 Day

Last modified on

2018 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012833


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name