chronic constipation complicated with type 2 diabetes mellitus
Conditions
Interventions
Patients were treated with Elobixibat 10 mg once daily before breakfast for 4 weeks. The dosage were fixed among the former 2 weeks, and could be changed from 2.5 mg up to 15 mg daily among the latter
Sponsors
Department of metabolic medicine, Faculty of Life science, Graduate School of Medical Sciences, Kumamoto University
The centor for clinical research of kumamoto university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients or hospitalized patients in Diabetes, Metabolism and Endocrinology of Kumamoto University Hospital, who were 20 years-old or older, suffering from chronic constipation complicated with type 2 diabetes mellitus, consenting for study paticipation. The drugs for constipation taken before this study would be stopped to be taken, except for Magnesium oxide when they participated in this study. Attending physician would select the continuation or discontinuation of taking Magnesium oxide among this study.
Exclusion criteria
Exclusion criteria: Patients meeting the following criteria will be excluded from the study: 1. Patients with infectious disease in acute phase, who had fever, or signs as getting cold 2. Patients who had past histories of surgeries of ileus, or hospitalization by ileus. 3. Patients with the constipation associated with colon cancers, rectul cancers, or resection of colonal polyps, including polypectomy 4. Patients with cardiovascular or cerebrovascular diseases occured within 12 weeks before the registration of this study 5. Patients with hepatic disfunction as the state of B or C in classification of Child-Pugh at the registration of this study 6. Patients with renal disfunction, which eGFR were lower than 30 ml/min/1.73m2 at the registration of this study 7. Patients with severe respiratory diseases,heart failure or arrhythmia. 8. Patients with mental disorder. 9. Patients who are pregnant or might be pregnant 10. Patients whom the physician in charge judges to be unsuitable for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The goal of this study is to evaluate the non-inferiority of elobixibat to lubiprostone. To ensure it, We compare the number of defecation with no laxatives in a week that passed firstly from which they started to take the drugs between two groups who take one of those drugs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The frequency of spontaneous defecation (times/ week), in which firstly patients take test drugs. 2. The frequency of spontaneous defecation (times/ week) a week after their first administration of test drugs. 3. The frequency of spontaneous defecation (times/ 4 weeks) in whole administration period (4 weeks). 4. The frequency of spontaneous defecation (times/ week) with no sensation of incomplete evacuation in 2 weeks which have passed from their first administration of test drugs. 5. The difference of the frequency (times/ week) in which they defecate spontaneously between the weeks before and after they have taken test drugs. 6. The difference of the frequency (times/ week) in which they defecate spontaneously with no sensation of incomplete evacuation between the weeks before and after they have taken test drugs. 7. The change of the hardness of stools which were classified by Bristol Stool Chart. 8. The frequency of rescue dose. If they have no defecation for 72 hours among this study, bisacodyl suppositories 10 mg daily could be used. 9. The happiness of patients evaluated by visual analogue scale. 10. The compliance of taking test drugs (times/ 2 weeks). 11. Any adverse events, and unexpected changes of laboratory data and vital signs. | — |
Countries
Japan
Contacts
Public ContactNorio Ishii
Faculty of Life science, Graduate School of Medical Sciences, Kumamoto University Department of metabolic medicine
Outcome results
None listed