A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

Astellas

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: YM060; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01274000

060-CL-701

Details and patient eligibility

About

A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.

Enrollment: 409 patients

Sex: Female

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
• Abdominal discomfort and/or pain during their non-menstrual period

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

409 participants in 4 patient groups, including a placebo group

placebo group

Placebo Comparator group

Treatment:

Drug: placebo

YM060 low-dose group

Experimental group

Treatment:

Drug: YM060

YM060 middle-dose group

Experimental group

Treatment:

Drug: YM060

YM060 high-dose group

Experimental group

Treatment:

Drug: YM060