A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients

Astellas

Status and phase

Completed

Phase 4

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Placebo

Drug: Ramosetron

Study type

Interventional

Funder types

Industry

Identifiers

NCT01225237

060-CL-501

Details and patient eligibility

About

A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.

Enrollment

296 patients

Sex

Male

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients meeting the Rome III Diagnostic Criteria
Loose (mushy) or watery stools within the last 3 months

Exclusion criteria

Patients with a history of surgical resection of the stomach, small intestine or large intestine
Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
Patients with a history or current diagnosis of colitis ischemic
Patients with a current diagnosis of enteritis infectious
Patients with a current diagnosis of hyperthyroidism or hypothyroidism
Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
Patients with a history or current diagnosis of malignant tumor
Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them