UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006663 |
|---|---|
| Receipt number | R000007871 |
| Scientific Title | Efficacy of ramosetron hydrochloride in male patients with diarrhea-predominant irritable bowel syndrome |
| Date of disclosure of the study information | 2011/11/10 |
| Last modified on | 2019/11/11 10:38:22 |
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Basic information
Public title
Efficacy of ramosetron hydrochloride in male patients with diarrhea-predominant irritable bowel syndrome
Acronym
Efficacy of ramosetron hydrochloride in male patients with diarrhea-predominant irritable bowel syndrome
Scientific Title
Efficacy of ramosetron hydrochloride in male patients with diarrhea-predominant irritable bowel syndrome
Scientific Title:Acronym
Efficacy of ramosetron hydrochloride in male patients with diarrhea-predominant irritable bowel syndrome
Region
| Japan |
Condition
Condition
Diarrhea-predominant irritable bowel syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) Efficacy of ramosetron hydrochloride in male patients with diarrhea-predominant irritable bowel syndrome
2) Usefulness of the Izumo scale for the monitoring of symptoms in patients with irritable bowel syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of ramosetron hydrochloride in patients with diarrhea-predominant irritable bowel syndrome (Indicator: GSRS).
Key secondary outcomes
Reliability and validity of the Izumo scale in the monitoring of symptoms in patients with irritable bowel syndrome
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1st step
Administration of ramosetron hydrochloride 5 microgram once a day for 4 weeks.
Interventions/Control_2
2nd step : increase
Administration of ramosetron hydrochloride 10 microgram once a day for 8 weeks.
2nd step : combination
Administration of ramosetron hydrochloride 5 microgram once a day and polycarbophil calcium for 8 weeks.
Interventions/Control_3
2nd step : combination
Administration of ramosetron hydrochloride 5 microgram once a day and polycarbophil calcium for 8 weeks.
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
1) At least 1 question with grade 4 or higher scores in questions 11, 12, and 14.
2) Subjects with written informed consent
Key exclusion criteria
1) Patients who have bowel move disturbance by organic lesion such as IBD (UC and Crohn disease etc.) and cancer.
2) Patients suspected of obstruction in stomach and intestines, and with a history of total gastric resection or bowel resection but not appendectomy
3) Patients with serious complications (liver, kidney, heart, lung, circulatory, or metabolic disorder)
4) Patients with a history of drug allergy
5) Others, including patients who are unfit for the study as determined by the attending doctor
6) Patients who are taking polycarbophil calcium.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
89-1, Enya, Izumo, Shimane 693-8501
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
si360405@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine, Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
| 2011 | Year | 11 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 03 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007871
