A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)

Diarrhea-predominant Irritable Bowel Syndrome Clinical Trial

Official title:

A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870895
• Other study ID #: 060-CL-702
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2013
• Last updated: October 9, 2015
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: October 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 577
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 64 Years

Eligibility

Inclusion 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:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea-predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• YM060
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monthly responder rate of global assessment of relief of overall IBS symptoms at final point		Up to 12 weeks	No
Primary	Monthly responder rate of stool form normalization at final point		Up to 12 weeks	No
Secondary	Monthly responder rate of global assessment of relief of abdominal pain/discomfort		Up to 12 weeks	No
Secondary	Monthly responder rate of global assessment of improvement of abnormal bowel habits		Up to 12 weeks	No
Secondary	Change in weekly average scores of severity of abdominal pain/discomfort		Up to 12 weeks	No
Secondary	Change in weekly average scores of stool form		Up to 12 weeks	No
Secondary	Safety assessment of YM060		Up to 12 weeks	No

External Links

•   Link to results on Astellas Clinical Study Results Web site