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

Diarrhea-predominant Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736423
• Other study ID #: 060-CL-703
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2012
• Last updated: October 9, 2015
• Start date: September 2012
• Est. completion date: May 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 64 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• YM060
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		up to 52 weeks	No
Primary	Monthly responder rate of stool form normalization		up to 52 weeks	No
Primary	Monthly responder rate of global assessment of relief of abdominal pain/discomfort		up to 52 weeks	No
Primary	Monthly responder rate of global assessment of improvement of abnormal bowel habits		up to 52 weeks	No
Primary	Change in weekly average of scores of severity of abdominal pain/discomfort		up to 52 weeks	No
Primary	Change in weekly average of scores of stool form		up to 52 weeks	No
Primary	Change in weekly average of stool frequency		up to 52 weeks	No
Primary	Rate of days without urgency		up to 52 weeks	No
Primary	Rate of days without feeling of incomplete bowel movement		up to 52 weeks	No
Primary	Change in entire Japanese version of Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) scores and pairwise IBS-QOL-J scores on the sub-scales		4, 8, 12, 28 and 52 weeks	No
Secondary	Safety assessed through AEs and clinical laboratory values		up to 52 weeks	No

External Links

•   Link to results on Astellas Clinical Study Results Web site