Unique ID issued by UMIN | UMIN000043911 |
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Receipt number | R000050099 |
Scientific Title | Examination of elobixibat's constipation restoration effect on chronic constipation patients-Retrospective observational research- |
Date of disclosure of the study information | 2021/04/14 |
Last modified on | 2022/02/08 11:24:16 |
Examination of elobixibat's constipation restoration effect on chronic constipation patients-Retrospective observational research-
Examination of elobixibat's constipation restoration effect on chronic constipation patients
Examination of elobixibat's constipation restoration effect on chronic constipation patients-Retrospective observational research-
Examination of elobixibat's constipation restoration effect on chronic constipation patients
Japan |
Chronic constipation
Gastroenterology | Adult |
Others
NO
To examine the effect of elobixibat on reversing constipation in patients with chronic constipation
Safety,Efficacy
Comparison of the urge for bowel movement before and after 2 weeks of treatment by elobixibat
Comparison of the urge for bowel movement before and after 6 and 10 weeks of treatment by elobixibat
Satisfaction with treatment after 2, 6, and 10 weeks of treatment by elobixibat
Bowel urgency after 2, 6, and 10 weeks of treatment by elobixibat
Time from intake of elobixibat to urge for bowel movement after 2, 6, and 10 weeks of treatment by elobixibat
Comparison of stool frequency before and after 2, 6, and 10 weeks of treatment by elobixibat
Comparison of stool type on the Bristol Stool Scale before and after 2, 6, and 10 weeks of treatment by elobixibat
Improvement of abdominal bloating after 2, 6, and 10 weeks of treatment by elobixibat
Improvement of abdominal pain after 2, 6, and 10 weeks of treatment by elobixibat
Discontinuation rate of stimulative laxatives after 2, 6, and 10 weeks of treatment by elobixibat
Use of concomitant drugs for constipation
Sub-analysis by the patients' background and the treatment status of elobixibat
Incidence rate and item of adverse events and adverse drug reaction
Discontinuation rate of elobixibat
Observational
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients 20 years or older
(2) Patients diagnosed with chronic constipation who have observation data on the urge for bowel movement from before to 2 weeks after starting treatment by elobixibat
(3) Patients who were administered elobixibat for at least 2 weeks continuously between April 19, 2018 and October 31, 2020 (Concomitant use of other drugs for the treatment of constipation should be allowed)
(1) Patients with a history of hypersensitivity to elobixibat
(2) Patients with confirmed or suspected bowel obstruction due to a tumor or hernia
(3) Patients with suspected constipation due to organic disease
(4) Patients who participated in a clinical trial or interventional study during the study period
(5) Patients who have been determined by a physician to be inappropriate to administer elobixibat
70
1st name | Takayuki |
Middle name | |
Last name | Ishikawa |
Nishi-Shinjyuku Kisaragi Clinic.
Internal medicine, Gastroenterology
160-0023
6-6-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo
03-3344-0529
t.ishikawa@me.com
1st name | Takayuki |
Middle name | |
Last name | Ishikawa |
Nishi-Shinjyuku Kisaragi Clinic.
Internal medicine, Gastroenterology
160-0023
6-6-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo
03-3344-0529
t.ishikawa@me.com
Nishi-Shinjyuku Kisaragi Clinic.
MOCHIDA PHARMACEUTICAL CO., LTD., EA Pharma Co.,Ltd.
Profit organization
Japan Conference of Clinical Research
1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo
03-6869-2920
nakagawa-kengo@3hcts.co.jp
NO
2021 | Year | 04 | Month | 14 | Day |
Published
https://www.shinryo-to-shinyaku.com/db/pdf/sin_0058_12_0865.pdf
80
The percentage of patients having defecation desire was 27.5% before the start of treatment, 76.3% at Week 2 (p<0.001), 97.0% at Week 6 (p<0.001), and 100% at Week 10.
2022 | Year | 01 | Month | 18 | Day |
Mean age was 35.1+-15.5 (SD) years, 83.8% (67/80) were female, and mean duration of constipation was 122.8+-99.4 (SD) months.
Adverse reactions were observed in 20 patients (25.0%), including diarrhea in 12 patients (15.0%), abdominal pain in 10 patients (12.5%), and nausea in 2 patients (2.5%). All of those were mild and non-serious.
Main results already published
2021 | Year | 02 | Month | 26 | Day |
2021 | Year | 03 | Month | 19 | Day |
2021 | Year | 03 | Month | 25 | Day |
2021 | Year | 05 | Month | 31 | Day |
To examine the effect of elobixibat on reversing constipation in patients with chronic constipation
2021 | Year | 04 | Month | 13 | Day |
2022 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050099
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