UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005577
Receipt number R000006598
Scientific Title An Open-Label Trial of Vesicare(Solifenacin Succinate) for the Treatment of Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
Date of disclosure of the study information 2011/05/09
Last modified on 2012/03/21 14:13:03

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Basic information

Public title

An Open-Label Trial of Vesicare(Solifenacin Succinate) for the Treatment of Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

Acronym

Effect of Vesicare on IBS-D

Scientific Title

An Open-Label Trial of Vesicare(Solifenacin Succinate) for the Treatment of Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

Scientific Title:Acronym

Effect of Vesicare on IBS-D

Region

Japan


Condition

Condition

Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

6-week, open-label trial of Vesicare in subjects with IBS-D.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

IBS symptoms of week 6 and IBS symptoms at week 0 (before the start of Vesicare)

Key secondary outcomes

IBS symptoms for the last week


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

One 5 mg Vesicare tablet taken orally per day for 2 weeks. If IBS symptoms for the last week improve, continue the dose for additional 4 weeks. If not, two 5mg tablets are taken for addtional 4 weeks. IBS symstoms of the week 6 and those of the week -1 are compared.

Interventions/Control_2


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

Subjects must have been diagnosed with IBS-D by a physician (Rome III Criteria).
Subject must be outpatients and be over 20 years of age.

Key exclusion criteria

Uncontrolled heart disease or arrhythmias.
History of major gastrointestinal surgery.
Urinary retention.
Narrow angle glaucoma.
myasthenia gravis.
Severe constipation.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasushi Fukushima

Organization

Tokyo-Eki Center-building Clinic

Division name

Department of Internal Medicine

Zip code


Address

3-14, Nihonbashi 3-chome, Chuo-ku, Tokyo, 103-0027 JAPAN

TEL

03-3517-6688

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasushi Fukushima

Organization

Tokyo-Eki Center-building Clinic

Division name

Department of Internal Medicine

Zip code


Address

3-14, Nihonbashi 3-chome, Chuo-ku, Tokyo, 103-0027 JAPAN

TEL

03-3517-6688

Homepage URL


Email

Yasushi.fukushima.c@tec-c.jp


Sponsor or person

Institute

Tokyo-Eki Center-building Clinic

Institute

Department

Personal name



Funding Source

Organization

Tokyo-Eki Center-building Clinic

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

医療法人社団旭和会 東京駅センタービルクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2011 Year 05 Month 09 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

Completed

Date of protocol fixation

2010 Year 11 Month 29 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 Day

Last follow-up date

2011 Year 05 Month 01 Day

Date of closure to data entry

2011 Year 07 Month 01 Day

Date trial data considered complete

2011 Year 10 Month 01 Day

Date analysis concluded

2012 Year 01 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 05 Month 09 Day

Last modified on

2012 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006598


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name