A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

Astellas

Status and phase: Completed; Phase 3

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Treatments: Drug: YM060

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736423

060-CL-703

Details and patient eligibility

About

To evaluate the efficacy and safety of YM060 once daily for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52 weeks).

Enrollment: 151 patients

Sex: Female

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Female patients who meet the following criteria:

1. Patients satisfying the Rome III Diagnostic Criteria
2. Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
3. Patients who have abdominal pain or discomfort
4. Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema

Exclusion criteria

Patients who meet any of the following criteria:

1. Patients with a history of surgical resection of the stomach,gallbladder, small intestine or large intestine
2. Patients with a history or current evidence of inflammatory bowel disease
3. Patients with a history or current evidence of colitis ischemic
4. Patients with concurrent infectious enteritis
5. Patients with concurrent hyperthyroidism or hypothyroidism
6. Patients with concurrent active peptic ulcer
7. Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 1 patient group

Female Patients with D-IBS

Experimental group

Treatment:

Drug: YM060