patients with diabetes complicated with chronic constipation
Conditions
Interventions
Elobixibat 5mg tablet is given orally at a dose of 2 tablets, once a day, before breakfast.
The treatment period is 8 weeks.
Elobixibat 10 mg/day is taken before breakfast on the day after the Visit 2
chronic constipation
Sponsors
Sone Masakatsu
EA Pharma co.,ltd.
MOCHIDA PHARMACEUTICAL CO., LTD
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of weekly frequency of spontaneous bowel movement between pre-treatment period and week 8 of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Endpoints for constipation: Weekly changes of the time to first spontaneous bowel movement* from pre-treatment to week 8 of administration Comparison of JPAC-QOL score between pre-treatment to week 4 or 8 of administration Weekly changes of Bristol stool form scale from pre-treatment to week 8 of administration Weekly changes of spontaneous and complete spontaneous bowel movement frequency** from pre-treatment to week 8 of administration Proportion of patients who had a spontaneous bowel movement within 24 or 48 hours after the initial administration *Bowel movement that occurs without use of intestinal laxative, enema or digital evacuation **Bowel movement without a sense of remaining stool and without use of intestinal laxative, enema or digital evacuation 2)Endpoints for glucose metabolism: Changes in the concentration of fasting blood glucose, HbA1c, glycoalbumin (GA) during 8 weeks and comparison between pre-treatment and week 8 of administration 3)Safety endpoints: Incidence of adverse events and adverse reactions | — |
Contacts
Public ContactYoshiaki Hishida
St. Marianna University
Outcome results
None listed