Randomized controlled trial to determine the efficacy and safety of ramosetron hydrochloride in male patients with diarrheal-predominant IBS symptom

Randomized controlled trial to determine the efficacy and safety of ramosetron hydrochloride in male patients with diarrheal-predominant IBS symptom - Randomized controlled trial of the effect of ramosetron hydrochloride on IBS symptom

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005237

Enrollment

Registered

2011-05-01

Start date

2011-06-01

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

Irritable bowel syndrome

Interventions

1. Test drug for 4 weeks -&gt

control drug for 4 weeks After oral administration of test drug (ramosetron hydrochloride) 5 maicro

g/dose once a day for 4 weeks, control drug (trimebutine maleate) 100 mg/dose three times a day is administered orally for 4 weeks. ikuro

2. Control drug for 4 weeks -&gt

test drug for 4 weeks After oral administration of control drug (trimebutine maleate) 100 mg/dose three times a day for 4 weeks, test drug (ramosetron hydrochloride) 5 maicro

g/dose once a day is administered orally for 4 weeks.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Selection criteria at the time obtain informed consent (at interim admission) 1) Patients who are diagnosed as diarrheal-predominant IBS by Rome III criteria. 2) Patients aged 20 or over at the time obtain informed consent. 3) Gender: male. 4) Consultation method: no specification 5) Patients who can provide the written informed consent. 2. Selection criteria at the time admission to the study. 1) Patients who discontinue use of any IBS medication at least 7 days prior to admission to the study. 2) Patients who wrote daily report of IBS symptom 7 days prior to admission to the study.

Exclusion criteria

Exclusion criteria: 1) Patients who have bowel move disturbance by organic lesion such as IBD(UC and crohn disease etc.) and cancer. 2) Patients suspected of obstruction in stomach and intestines, and with a history of total gastric resection or bowel resection but not appendicectomy 3) Patients with serious complications (liver, kidney, heart, lung, circulatory, or metabolic disorder) 4) Patients with a history of drug allergy 5) Patients who are taking psychotropic drug 6) Others, including patients who are unfit for the study as determined by the attending doctor

Design outcomes

Primary

Measure	Time frame
IBS-QOL-J	—

Secondary

Measure	Time frame
1.Subjective symptom (abdominal pain, abdominal fullness) 2.Defecation (bowel frequency, stool form) 3. Blood cytokine level 4.Serum concentration of serotonin 5.Patient's impression	—

Countries

Japan

Contacts

Public ContactKazuhiko Nakamura

Kyushu University Hospital Department of Hepatology and Pancreatology

Outcome results

None listed

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