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

JRCT ID: jRCTs031200347

Registered date:05/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Functional dyspepsia
• Date of first enrollment: 05/02/2021
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Cholestimide 1500mg bid (3000mg /day) 4weeks

Outcome(s)

• Primary Outcome: Overall treatment efficacy (OTE) at 4 weeks of drug administration

Secondary Outcome

Incidence of adverse events
Elimination rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kessoku Takaomi
• Source(s) of Monetary Support: Yokohama City University