Examination of efficacy and safety of elobixibat in patients with chronic constipation by combination with or switching from existing therapy - A Retrospective Observational Study-

Examination of efficacy and safety of elobixibat in patients with chronic constipation by combination with or switching from existing therapy - A Retrospective Observational Study- - Examination of efficacy and safety of elobixibat in patients with chronic constipation by combination with or switching from existing therapy - A Retrospective Observational Study-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049639

Enrollment

300

Registered

2022-11-29

Start date

2022-11-25

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women 18 years of age or older at the time of starting treatment with elobixibat. 2. Patients who are judged by the physician to be inadequate for treatment with existing therapies alone in terms of efficacy and safety. 3. Patients with chronic constipation who meet RomeIV criteria at the start of treatment with elobixibat. 4. Patients who were prescribed an existing therapy for at least 1 week and then started on elobixibat during the study period, either by combination with or switching from an existing therapy. 5. Patients who have a record of treatment progress for at least 2 weeks after elobixibat administration and a record of bowel movements before and after elobixibat administration during the study period.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to elobixibat or who were prescribed elobixibat outside the approved indications, dosage and administration during the observation period. 2. Patients who participated in clinical trials or interventional studies during the observation period.

Design outcomes

Primary

Measure	Time frame
Comparison of spontaneous bowel movements before and 2 weeks after elobixibat treatment	—

Secondary

Measure	Time frame
1. Stool shape (Bristol Stool form Scale) before and after 2 weeks of treatment 2. Comparison of sensation of incomplete evacuation before and after 2 weeks of treatment 3. Comparison of presence/absence of straining before and after 2 weeks of treatment 4. Comparison of abdominal pain before and after 2 weeks of treatment 5. Comparison of abdominal bloating before and after 2 weeks of treatment 6. Comparison of anorectal blockage before and after 2 weeks of treatment 7. Comparison of nausea before and after 2 weeks of treatment 8. By patient background, elobixibat administration status, and previous or concomitant treatment for constipation subgroup analysis 9. Adverse events and adverse drug reactions and their incidence 10. Discontinuation rate of elobixibat	—

Measure

Time frame

1. Stool shape (Bristol Stool form Scale) before and after 2 weeks of treatment 2. Comparison of sensation of incomplete evacuation before and after 2 weeks of treatment 3. Comparison of presence/absence of straining before and after 2 weeks of treatment 4. Comparison of abdominal pain before and after 2 weeks of treatment 5. Comparison of abdominal bloating before and after 2 weeks of treatment 6. Comparison of anorectal blockage before and after 2 weeks of treatment 7. Comparison of nausea before and after 2 weeks of treatment 8. By patient background, elobixibat administration status, and previous or concomitant treatment for constipation subgroup analysis 9. Adverse events and adverse drug reactions and their incidence 10. Discontinuation rate of elobixibat

—

Countries

Japan

Contacts

Public ContactMomoko Watanabe

SRD Co., Ltd. Clinical Research Department

md-ex-retro@cro-srd.co.jp03-5543-0302

Outcome results