Unique ID issued by UMIN | UMIN000036163 |
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Receipt number | R000041191 |
Scientific Title | Efficacy and safety of elobixibat before dinner administration in patients with functional constipation |
Date of disclosure of the study information | 2019/03/11 |
Last modified on | 2019/10/11 10:43:33 |
Efficacy and safety of elobixibat before dinner administration in patients with functional constipation
Efficacy and safety of elobixibat before dinner administration in patients with functional constipation
Efficacy and safety of elobixibat before dinner administration in patients with functional constipation
Efficacy and safety of elobixibat before dinner administration in patients with functional constipation
Japan |
functional constipation
Hepato-biliary-pancreatic medicine |
Others
NO
We aim to examine the efficacy and safety of elobixibat before dinner administration in patients with functional constipation.
Safety,Efficacy
Comparison of frequency of spontaneous bowel movements between baseline and week 4 of administration
Change of the time to first spontaneous bowel movement from baseline to 8 weeks after administration
Comparison of JPAC-QOL score between baseline and week 4 or 8 of administration
Change of Bristol Stool Form Scale (BSFS) from baseline to 8 weeks after administration
Change of VAS of abdominal pain from baseline to 8 weeks after administration
Change of frequency of spontaneous bowel movements from baseline to 8 weeks after administration
Proportion of patients who had
a spontaneous bowel movement within 24 or 48 hours after the initial administration
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with 20 years or older at the time before administration
2. Patients who were diagnosed functional constipation by ROME IV criteria at the time before administration
3. Patients who had fewer than 3 times spontaneous bowel movements per week at the time before administration
4. Patients who were administered elobixibat before dinner during study period
1 Patients who were suspected of organic constipation
2 Patients who were taking constipation related medicines* within 2 weeks before elobixibat administration
3 Patients with medication history for psychotropics, antidepressants and/or anxiolytics
*Constipation related medicines
Laxatives (Magnesium oxide preparation, sodium picosulfate, sennoside, etc.)
Chinese herbal medicines having indication of constipation (Daio-kanzo-to, Choi-joki-to, Dai-saiko-to, etc.)
Therapeutic medicines of irritable bowel syndrome (Ramosetron hydrochloride, calcium polycarbophil, trimebutine maleate etc.)
Prokinetics (Mosapride citrate, metoclopramide, domperidone, etc.)
30
1st name | Takeo |
Middle name | |
Last name | Odaka |
ODAKA CLINIC
Director of the clinic
275-0028
1-12-3, Kanadenomori, Narashino-shi, Chiba, Japan
047-477-5525
info@odaka-clinic.com
1st name | Takeo |
Middle name | |
Last name | Odaka |
ODAKA CLINIC
Director of the clinic
275-0028
1-12-3, Kanadenomori, Narashino-shi, Chiba, Japan
047-477-5525
info@odaka-clinic.com
ODAKA CLINIC
EA Pharma Co., Ltd.
Profit organization
Adachikyousai Hospital Institutional Review Board
1-36-8, Yanagihara, Adachi-ku, Tokyo, 120-0022, Japan
03-3881-6116
yama.chike2@gmail.com
NO
尾髙内科・胃腸クリニック(千葉県)
2019 | Year | 03 | Month | 11 | Day |
Unpublished
41
Completed
2019 | Year | 01 | Month | 17 | Day |
2019 | Year | 01 | Month | 21 | Day |
2019 | Year | 01 | Month | 21 | Day |
2019 | Year | 02 | Month | 28 | Day |
nothing
2019 | Year | 03 | Month | 11 | Day |
2019 | Year | 10 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041191
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