Effects of Elobixibat in patients with heart failure complicated with chronic constipatio
- Conditions
- Heart failure complicated with chronic constipationchronic constipation
- Registration Number
- JPRN-jRCTs071190055
- Lead Sponsor
- Tsujita Kenichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Patients with chronic constipation who meet every those following criteria
(At the time of registration(enrollment))
1.Patients with chronic constipation who meet every those following criteria
1) Meet 2 or more of the following six items
a. Straining during more than one-fourth (25%) of defections
b. Lumpy or hard stools (BSFS 1-2) more than one-fourth (25%) of defections
c. Sensation of incomplete evacuation more than one-fourth (25%) of defections
d. Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defections
e. Manual maneuvers to facilitate more than one-fourth (25%) of defections (eg, digital evacuation, support of the pelvic floor)
f. Fewer than 3 spontaneous bowel movement per week
2) Meet every those following 3 items
a. Rare to have loose stools without using laxtive
b. Never been given diagnosis as irriable bowel syndrome
c. Symptoms have been oresent since more than 6 months and meet the criteria 1.-1) for last 3 months..
2.Outpatients with stable heart failure who meet every those following criteria
1) Classification of NYHA cardiac function is belong to II or III.
2) No change in any prescription for heart failure within 12 weeks before obtaining Informed Consent
3) No hospitalization history for heart disease treatment within 6 months before obtaining Informed Consent
4) Patients judged by doctors to be able to observe during the pre-observation and administration period
3.Male and female over 20 years old at the date of Informed Consent
4.Patients who are given sufficient description about participation in this study and sufficiently understand it, providing their consent in document by their own free will
5.Patients who can write a defecation diary during the study period
Patients who is applicable those followings to be excluded
(At the time of registration(enrollment), at theVisit 2)
1.Patients with a history of hypersensitivity to Elobixibat
2.Patients with confirmed or suspected bowel obstruction due to tumor, hernia, etc.
3.Patients with severe hepatopathy (AST or ALT is 3 times or more for upper limit of in-hospital standard.)
4.Patients to be suspected of having biliary atresia or a reducing secretion of bile acid
5.Patients suspected of organic constipation
6.Female patients who are pregnant, breastfeeding, or hope to raise children
7.Patients who are taking bile acid preparations (ursodeoxycholic acid, chenodeoxycholic acid), aluminum-containing preparations (sucralfate hydrate, aldioxa, etc.), cholestyramine, colestimide or midazolam
8.Patients who are judged to be ineligible for this research by investigator because of threatening the safety or poor protocol compliance
(At the Visit 2)
9.Patients who have taken Elobixibat during the previous observation period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method