Unique ID issued by UMIN | UMIN000023399 |
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Receipt number | R000026901 |
Scientific Title | Efficacy of Ramosetron on Irritable Bowel Syndrome - like Symptoms in Patients with Inactive Inflammatory Bowel Disease - A Randomized, Double-blind, Placebo-Controlled Study - |
Date of disclosure of the study information | 2016/07/30 |
Last modified on | 2019/03/27 09:13:58 |
Efficacy of Ramosetron on Irritable Bowel Syndrome - like Symptoms in Patients with Inactive Inflammatory Bowel Disease - A Randomized, Double-blind, Placebo-Controlled Study -
Efficacy of Ramosetron on Irritable Bowel Syndrome - like Symptoms in Patients with Inactive Inflammatory Bowel Disease
Efficacy of Ramosetron on Irritable Bowel Syndrome - like Symptoms in Patients with Inactive Inflammatory Bowel Disease - A Randomized, Double-blind, Placebo-Controlled Study -
Efficacy of Ramosetron on Irritable Bowel Syndrome - like Symptoms in Patients with Inactive Inflammatory Bowel Disease
Japan |
Inactive Inflammatory bowel disease with Irritable bowel syndrome-like symptoms diadnosed by Rome III criteria
Gastroenterology |
Others
NO
To assess the efficacy with the use of ramosetron on Irritable bowel syndrome-like symptoms in patients with Inactive Inflammatory bowel disease
Efficacy
Monthly responder rates of global assessment of relief of overall IBS symptoms,
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
Ramosetron
Placebo
20 | years-old | <= |
70 | years-old | > |
Male and Female
1)Inactive IBD patients with diarrhea predominant IBS-like symptom diagnosed according to the Rome III criteria.
2)The remission stage of IBD was defined as follows. CD: Crohn's disease activity Index index under 150, UC: clinical activity index for the evaluation of patients with ulcerative colitis index under 4 and CRP under 0.3.
3)They had type 6 or 7 stool form, as scored by BSFS, recorded during the baseline period; had bowel movements 2 days or more per week.
4)Organic diseases were excluded by total colonoscopy or double-contrast barium enema.These examinations had to have been performed within 2 years before the provisional registration of subjects and after the onset of IBS symptoms.
5)They recorded all items in the patient diary for 5 days or more during the baseline period.
Candidates were excluded from participation if they had a history of abdominal surgery, had serious infectious colitis, had a history of ischemic colitis, had ischemic colitis.
70
1st name | Hiroto |
Middle name | |
Last name | Miwa |
Hyogo College of Medicine
Division of Gastroenterology, Department of Internal Medicine
663-8501
Nishinomiya
0798456661
tomita@hyo-med.ac.jp
1st name | Toshihiko |
Middle name | |
Last name | Tomita |
Dr.
Division of Gastroenterology, Department of Internal Medicine
663-8501
Nishinomiya
0798456661
tomita@hyo-med.ac.jp
Hyogo College of Medicine
Astellas Pharma Inc.
Profit organization
Hyogo College of Medicine
1-1, Mukogawachou, Nishinomiya, Hyogo
0798-45-6662
tomita@hyo-med.ac.jp
NO
2016 | Year | 07 | Month | 30 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 29 | Day |
2015 | Year | 11 | Month | 16 | Day |
2016 | Year | 07 | Month | 30 | Day |
2019 | Year | 03 | Month | 26 | Day |
2016 | Year | 07 | Month | 29 | Day |
2019 | Year | 03 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026901
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