Efficacy of cholestimide in patients with functional dyspepsia refractory to standard therapy

Efficacy of cholestimide in patients with functional dyspepsia refractory to standard therapy: a phase II, single-center, single-arm, pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200347

Enrollment

Registered

2021-02-05

Start date

2021-02-05

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 dyspepsia Functional dyspepsia

Interventions

Cholestimide 1500mg bid (3000mg /day) 4weeks

Functional dyspepsia treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with functional dyspepsia by ROME IV criteria (2) Patients taking acotiamide for more than 2 weeks but do not achieve symptom improvement (3) Patients judged by the physicians to be capable of reporting the patient reported outcomes (4) Patients who have provided written consent to participate in the study

Exclusion criteria

Exclusion criteria: (1) Patients with a history of hypersensitivity to any component of the drug (cholestimide) (2) Patients with complete biliary obstruction (3) Patients with gastrointestinal obstruction (4) Patients who are already taking cholestimide for other diseases (5) Patients judged by the physicians to be inappropriate to participate in the study based on concomitant therapy or medical findings

Design outcomes

Primary

Measure	Time frame
Overall treatment efficacy (OTE) at 4 weeks of drug administration	—

Secondary

Measure	Time frame
Incidence of adverse events Elimination rate	—

Contacts

Public ContactTakaomi Kessoku

Yokohama City University Hospital

takaomik@yokohama-cu.ac.jp+81-45-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026