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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004128
Receipt No. R000002646
Scientific Title Pathologic and therapeutic evaluation of irritable bowel syndrome and ulcerative colitis
Date of disclosure of the study information 2010/08/31
Last modified on 2017/09/07

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Basic information
Public title Pathologic and therapeutic evaluation of irritable bowel syndrome and ulcerative colitis
Acronym Investigation of irritable bowel syndrome and ulcerative colitis
Scientific Title Pathologic and therapeutic evaluation of irritable bowel syndrome and ulcerative colitis
Scientific Title:Acronym Investigation of irritable bowel syndrome and ulcerative colitis
Region
Japan

Condition
Condition Irritable bowel syndrome and ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the effectiveness of 5-HT3 receptor antagonistin patients with irritable bowel syndrome or ulcerative colitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of symptoms
Key secondary outcomes Compare serotonin or serotonin related gene expression and polymorphisms among the patients with irritable bowel syndrome, ulcerative colitis and sex and age matched controls to identify the predictive factors for the effectiveness of 5-HT3 receptor antagonist


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treat patient with irritable bowel syndrome using 5ug/day 5HT3 receptor antagonist and ulcerative colitis using 10ug/day for 4weeks
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 Patients with irritable bowel syndrome, ulcerative colitis and sex and age matched controls who plan colonoscopy
Key exclusion criteria Using SSRI or prokinetics.
Patients with constipation, hemorrhagic diseases, insulin-dependent diabetes mellitus, cirrhosis or renal failure.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiotani Akiko
Organization Kawasaki Medical School
Division name Gastroentrology
Zip code
Address 577 Matsushima Kurashiki city 701-0192Japan
TEL 81864621111
Email shiotani@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ms. Yamazi
Organization Kawasaki Medical School
Division name Research support
Zip code
Address 577 Matsushima Kurashiki city
TEL 81864621111
Homepage URL
Email kmsrec@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School

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
2010 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2015 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 02 Day
Last follow-up date
2016 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 30 Day
Last modified on
2017 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002646

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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