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

Irritable Bowel Syndrome Clinical Trial

Official title:

Phase II Study of YM060 - Double-blind, Parallel-group Comparative Study in Patients (Female) With Diarrhea-predominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274000
• Other study ID #: 060-CL-701
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2011
• Last updated: October 9, 2015
• Start date: November 2010
• Est. completion date: October 2011

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 64 Years

Eligibility

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

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
• 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	Responder rate of patients reported global assessment of relief of IBS symptoms		for 4 weeks	No
Secondary	Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain		for 4 weeks	No
Secondary	Responder rate of patients reported assessment of improvement of abnormal bowel habits		for 4 weeks	No
Secondary	Change in weekly average scores of stool form (appearance)		Baseline and for 4 weeks	No
Secondary	Safety assessed by the incidence of adverse events and abnormal values in lab-tests		for 4 weeks	No

External Links

•   Link to results on Astellas Clinical Study Results Web site
•   Link to Results on JAPIC - enter 140635 in the JapicCTI-RNo. field (Japanese record)