A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

• ClinicalTrials.gov Identifier: NCT00918411
• Recruitment Status: Completed
• First Posted: June 11, 2009
• Last Update Posted: October 12, 2015
• Sponsor: Astellas Pharma Inc
• Information provided by (Responsible Party): Astellas Pharma Inc

Tracking Information

• First Submitted Date: June 9, 2009
• First Posted Date: June 11, 2009
• Last Update Posted Date: October 12, 2015
• Study Start Date: June 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 10, 2009): IBS severity index (Japanese version) [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 10, 2009)

• Patient reported global assessment of relief of IBS symptoms [ Time Frame: 12 weeks ]
• Patient reported assessment of relief of abdominal discomfort and/or pain [ Time Frame: 12 weeks ]
• Patient reported assessment of improvement of abdominal bowel habits [ Time Frame: 12 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
• Official Title: Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - A Preliminary Study to Evaluate the Co-primary Endpoint in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
• Brief Summary: The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant)
• Condition: Irritable Bowel Syndrome

Intervention

• Drug: Ramosetron
  oral
  Other Names:

  • Irribow
  • YM060
• Drug: Placebo
  oral

Study Arms

• Experimental: Ramosetron group
  oral
  Intervention: Drug: Ramosetron
• Placebo Comparator: Placebo group
  oral
  Intervention: Drug: Placebo

Publications *

• Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Randomized, placebo-controlled, phase IV pilot study of ramosetron to evaluate the co-primary end points in male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 16;11:8. doi: 10.1186/s13030-017-0093-9. eCollection 2017.
• Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 11;11:7. doi: 10.1186/s13030-017-0092-x. eCollection 2017.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 21, 2010): 98
• Original Estimated Enrollment (submitted: June 10, 2009): 60
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients meeting the Rome III Diagnostic Criteria
• Loose (mushy) or watery stools within the last 3 months

Exclusion Criteria:

• Patients having hyperthyroidism or hypothyroidism

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 20 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00918411
• Other Study ID Numbers: 060-CL-500
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Astellas Pharma Inc
• Study Sponsor: Astellas Pharma Inc
• Collaborators: Not Provided

Investigators

• Study Chair: Use Central Contact; Astellas Pharma Inc

• PRS Account: Astellas Pharma Inc
• Verification Date: October 2015