Efficacy and safety of elobixibat in hemodialysis patients with chronic constipation -Retrospective observation research-

Efficacy and safety of elobixibat in hemodialysis patients with chronic constipation - Efficacy and safety of elobixibat in hemodialysis patients with chronic constipation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037285

Enrollment

Registered

2019-07-05

Start date

2019-07-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic constipation complicated with chronic renal disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with 20 years or older 2. Patients more than 6 months after hemodialysis introduction 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 starts Elobixibat administration from April 19, 2018 to January 18, 2019

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 whose physicians judged that administration of elobixibat was inappropriate

Design outcomes

Primary

Measure	Time frame
Comparison of frequency of spontaneous bowel movement between baseline and week 12 of administration	—

Secondary

Measure	Time frame
Changes in the frequency of spontaneous bowel movements during 12 weeks Changes in the Bristol Stool Form Scales during 12 weeks and comparison between baseline to at weeks 12 of administration Comparison in the patient satisfaction (VAS) between baseline and at weeks 12 of administration Comparison in the Constipation Scoring System between baseline and at weeks 12 of administration Changes in the body weight gain of interdialytic period per week during 12 weeks and comparison between baseline and at weeks 12 of administration Changes in the concentration of serum phosphorus, potassium, sodium, chloride, calcium, albumin during 12 weeks and comparison between baseline and at weeks 12 of administration Comparison in the concentration of serum LDL-cholesterol between baseline and at weeks 12 of administration	—

Measure

Time frame

Changes in the frequency of spontaneous bowel movements during 12 weeks Changes in the Bristol Stool Form Scales during 12 weeks and comparison between baseline to at weeks 12 of administration Comparison in the patient satisfaction (VAS) between baseline and at weeks 12 of administration Comparison in the Constipation Scoring System between baseline and at weeks 12 of administration Changes in the body weight gain of interdialytic period per week during 12 weeks and comparison between baseline and at weeks 12 of administration Changes in the concentration of serum phosphorus, potassium, sodium, chloride, calcium, albumin during 12 weeks and comparison between baseline and at weeks 12 of administration Comparison in the concentration of serum LDL-cholesterol between baseline and at weeks 12 of administration

—

Countries

Japan

Contacts

Public ContactTakefumi Shono

Hyakutake Clinic Vice-principal

tkfm-shn.3@smile.ocn.ne.jp0947-42-9100

Outcome results