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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005577
Receipt No. 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

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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
Institute Tokyo-Eki Center-building Clinic
Institute
Department

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
URL(English) https://upload.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


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