A study of factors which predicts the therapeutic effect of acotiamide on abdominal symptoms in patients with Functional dyspepsia.

A study of factors which predicts the therapeutic effect of acotiamide on abdominal symptoms in patients with Functional dyspepsia. - A study of factors which predicts the therapeutic effect of acotiamide on abdominal symptoms in patients with Functional dyspepsia.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036265

Enrollment

200

Registered

2019-03-22

Start date

2017-05-31

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults who have any upper gastrointestinal symptoms for more than one month, have a medical institution visit and no organic abnormalities have been pointed out by examinations including an endoscope, and are considered as functional upper gastrointestinal symptoms case. 2) Age at registration: 20 to 85 years, no gender (at registration) 3) Those who gave a written and verbal explanation and obtained written consent for participation in research freely. 4) The patient's general condition is good (performance status 0)

Exclusion criteria

Exclusion criteria: 1) Those that have been prescribed acid secretion inhibitors and digestive tract movement improving agents within one month. 2) Person who are taking non-steroidal analgesics,steroids, immunosuppressants 3) Endoscopic examination with organic abnormalities that cause symptoms such as erosive reflux esophagitis 4) There is no problem if heartburn and IBS symptoms accompany, but heartburn and IBS symptoms dominate 5) Person who is suspected of mental illness 6) Potentially pregnant, pregnant 7) Person who have serious systemic illness 8) Person who have a history of upper abdominal surgery for esophagus, stomach and duodenum (except for endoscopic treatment), or if you are planning 9) Person who have uncontrolled diabetes 10) Those who received H. pylori eradication treatment within 6 months 11) In addition, those who the research investigator or co-investigator judged as inappropriate for study participation

Design outcomes

Primary

Measure	Time frame
Evaluation of effects on GOS and OTE questionnaires at 2 and 4 weeks of medication	—

Secondary

Measure	Time frame
Serum helicobacter pylori antibody Serum pepsinogen levels Adverse events, medication status, presence of constipation, duration of illness, symptoms, endoscopic findings	—

Countries

Japan

Contacts

Public ContactReina Ohba

Akita University Graduate School of Medicine Department of Gastroenterology and Neurology

reina@doc.med.akita-u.ac.jp018-884-6104

Outcome results