Chronic constipation complicated with chronic renal disease
Conditions
Interventions
None listed
Sponsors
Hyakutake Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with 18 years or older 2. Patients with chronic kidney disease who have been on hemodialysis for more than 3 months 3. Patients with chronic constipation who must include 2 or more the following 6 items a. Straining during more than one-fourth of defecations b. Lumpy or hard stools (BSFS 1or 2) more than one-fourth of defecations c. Sensation of incomplete evacuation more than one-fourth of defecations d. Sensation of anorectal obstruction/blockage more than one-fourth of defecations e. Manual maneuvers to facilitate more than one fourth of defecations f. Fewer than 3 spontaneous bowel movements per week 4. Patients who have received elobixibat for at least 24 weeks according to the dosage and administration during the period under investigation (concomitant use with other laxatives is allowed)
Exclusion criteria
Exclusion criteria: 1. Patients who had a history of hypersensitivity of elobixibat 2. Patients who are confirmed or suspected intestinal obstruction due to tumor, hernia etc. 3. Patients who are suspected constipation due to organic disease 4. Patients who participated in clinical trials or intervention studies during the observation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of spontaneous bowel movement frequency before the start of administration and at the last observation after Week 24 of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of spontaneous bowel movement frequency before and after treatment over time 2. Comparison of the Bristol Stool Form Scale (BSFS) before and after treatment over time 3. Comparison of patient satisfaction before and after treatment over time 4. Comparison of Constipation Scoring System (CSS) before and after treatment over time 5. Comparison of inter-dialysis weight gain before and after treatment over time 6. Comparison of serum phosphorus, potassium, sodium, chloride, calcium, albumin before and after treatment over time 7. Comparison of serum LDL-cholesterol and serum total cholesterol before and after treatment over time 8. Comparison of total lymphocyte counts before and after treatment over time 9. Change of patient satisfaction ("0. Very satisfied" and "1. Satisfied" rates) before and after treatment over time 10. Relationship between patient satisfaction and each efficacy endpoint 11. Comparison of intestinal microbiota in patients with adequate and inadequate response to elobixibat treatment 12. Relationship between intestinal microflora and blood urea toxin 13. Comparison of nutritional indices (albumin, serum total cholesterol, total lymphocyte count, and CONUT score calculated from these indices) in patients with satisfactory response to elobixibat and those with insufficient response 14. Adverse events and adverse drug reactions and their incidence 15. Discontinuation rate | — |
Countries
Japan
Contacts
Public ContactMomoko Watanabe
SRD Co., Ltd. Clinical Research Department
Outcome results
None listed