Efficacy and safety of elobixibat before dinner administration in patients with functional constipation

Efficacy and safety of elobixibat before dinner administration in patients with functional constipation - Efficacy and safety of elobixibat before dinner administration in patients with functional constipation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036163

Enrollment

Registered

2019-03-11

Start date

2019-01-21

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

functional constipation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with 20 years or older at the time before administration 2. Patients who were diagnosed functional constipation by ROME IV criteria at the time before administration 3. Patients who had fewer than 3 times spontaneous bowel movements per week at the time before administration 4. Patients who were administered elobixibat before dinner during study period

Exclusion criteria

Exclusion criteria: 1 Patients who were suspected of organic constipation 2 Patients who were taking constipation related medicines* within 2 weeks before elobixibat administration 3 Patients with medication history for psychotropics, antidepressants and/or anxiolytics *Constipation related medicines Laxatives (Magnesium oxide preparation, sodium picosulfate, sennoside, etc.) Chinese herbal medicines having indication of constipation (Daio-kanzo-to, Choi-joki-to, Dai-saiko-to, etc.) Therapeutic medicines of irritable bowel syndrome (Ramosetron hydrochloride, calcium polycarbophil, trimebutine maleate etc.) Prokinetics (Mosapride citrate, metoclopramide, domperidone, etc.)

Design outcomes

Primary

Measure	Time frame
Comparison of frequency of spontaneous bowel movements between baseline and week 4 of administration	—

Secondary

Measure	Time frame
Change of the time to first spontaneous bowel movement from baseline to 8 weeks after administration Comparison of JPAC-QOL score between baseline and week 4 or 8 of administration Change of Bristol Stool Form Scale (BSFS) from baseline to 8 weeks after administration Change of VAS of abdominal pain from baseline to 8 weeks after administration Change of frequency of spontaneous bowel movements from baseline to 8 weeks after administration Proportion of patients who had a spontaneous bowel movement within 24 or 48 hours after the initial administration	—

Measure

Time frame

Change of the time to first spontaneous bowel movement from baseline to 8 weeks after administration Comparison of JPAC-QOL score between baseline and week 4 or 8 of administration Change of Bristol Stool Form Scale (BSFS) from baseline to 8 weeks after administration Change of VAS of abdominal pain from baseline to 8 weeks after administration Change of frequency of spontaneous bowel movements from baseline to 8 weeks after administration Proportion of patients who had a spontaneous bowel movement within 24 or 48 hours after the initial administration

—

Countries

Japan

Contacts

Public ContactTakeo Odaka

ODAKA CLINIC Director of the clinic

info@odaka-clinic.com047-477-5525

Outcome results