A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

Astellas

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Ramosetron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918411

060-CL-500

Details and patient eligibility

About

The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).

Enrollment: 98 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 having hyperthyroidism or hypothyroidism

Trial design

98 participants in 2 patient groups, including a placebo group

Ramosetron group

Experimental group

Description:

oral

Treatment:

Drug: Ramosetron

Placebo group

Placebo Comparator group

Description:

oral

Treatment:

Drug: Placebo