UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004128 |
|---|---|
| Receipt number | 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 16:41:39 |
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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
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
kmsrec@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002646
