Effects of Elobixibat in patients with diabetes and chronic constipatio

Not Applicable

• Conditions: patients with diabetes complicated with chronic constipation

• Registration Number: JPRN-jRCTs031190092
• Lead Sponsor: Sone Masakatsu

Brief Summary

Elobixibat 10 mg / day was administered to diabetic patients with chronic constipation for 8 weeks, as a result, the effect of improving chronic constipation was shown. No significant change was shown in each parameter of glycometabolism. No new safety concerns were found in this study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-06
• Study Completion: 2021-03-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Patients who meet all of the following criteria are eligible.
(At Informed Consent)
1) Diabetic patients complicated with chronic constipation * who are visiting an out-patient clinic (irrespective of the disease type)
* Following criteria were established in reference to Rome IV functional constipation
Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
(a) Must include 2 or more of the following
>Straining during more than one-fourth(25percent) of defecations
>Sensation of anorectal obstruction/blockage more than one-fourth (25percent) of defecations
>Lumpy or hard stools more than one-fourth (25percent) of defecations
>Manual maneuvers to facilitate more than one fourth (25percent) of defecations (eg, digital evacuation, support of the pelvic floor)
>Sensation of incomplete evacuation more than one-fourth (25percent) of defecations
>Fewer than 3 spontaneous bowel movements per week
(b) Loose stools are rarely present without the use of laxatives
(c) Insufficient criteria for irritable bowel syndrome (IBS)
2) Male and female patients aged >=20 years at the time of Informed Consent
3) Patients who voluntarily gave written Informed Consent after sufficient explanation about this study was provided for good understanding
(At the registration)
4) Patients whose spontaneous bowel movement ** frequency was <6 times during 2 weeks of Baseline period **
* Bowel movement that occurs without use of intestinal laxative, enema or digital evacuation
** Baseline period is defined as the last 2 weeks of the observation period

Exclusion Criteria

Patients who meet any of the following conditions are excluded from this study.
(At Informed Consent and the registration)
1)Patients with a history of hypersensitivity to elobixibat
2)Patients with confirmed or suspected intestinal obstruction due to tumor, hernia, etc.
3)Patients with serious hepatic impairment (an elevation of at least 3x of the upper limit of normal AST and/or ALT)
4)Patients suspected of biliary atresia or a decreased secretion of bile acid
5)Patients suspected of organic constipation
6)Female patients who are pregnant, breast-feeding or wish to be pregnant
7)Patients under treatment with bile acid products (ursodeoxycolic acid, chenodeoxycholic acid), aluminum containing products (sucralfate hydrate, aldioxa, etc.), cholestyramine, colestimide, digoxin, dabigatran etexilate mesylate or midazolam
8) Patients whose hypoglycemic drug(s) was changed within 12 weeks prior to Informed Consent
9)Patients whose fluctuations in HbA1c levels were >=0.5% within 12 weeks prior to Informed Consent
10)Patients with a history of hospitalization for a blood glucose control purpose within 6 months prior to Informed Consent
11)Patients who were considered as ineligible by the investigator for safety or poor protocol compliance
(At the registration)
12)Patients who received elobixibat during the Baseline period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified