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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01870895
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE June 4, 2013
First Posted Date  ICMJE June 6, 2013
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
  • Monthly responder rate of global assessment of relief of overall IBS symptoms at final point [ Time Frame: Up to 12 weeks ]
  • Monthly responder rate of stool form normalization at final point [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
  • Monthly responder rate of global assessment of relief of abdominal pain/discomfort [ Time Frame: Up to 12 weeks ]
  • Monthly responder rate of global assessment of improvement of abnormal bowel habits [ Time Frame: Up to 12 weeks ]
  • Change in weekly average scores of severity of abdominal pain/discomfort [ Time Frame: Up to 12 weeks ]
  • Change in weekly average scores of stool form [ Time Frame: Up to 12 weeks ]
  • Safety assessment of YM060 [ Time Frame: Up to 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)
Official Title  ICMJE A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diarrhea-predominant Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: YM060
    oral
    Other Names:
    • ramosetron,
    • Irribow
  • Drug: Placebo
    oral
Study Arms  ICMJE
  • Experimental: YM060 group
    Intervention: Drug: YM060
  • Placebo Comparator: Placebo group
    Intervention: Drug: Placebo
Publications * Fukudo S, Kinoshita Y, Okumura T, Ida M, Akiho H, Nakashima Y, Nishida A, Haruma K. Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. Gastroenterology. 2016 Feb;150(2):358-66.e8. doi: 10.1053/j.gastro.2015.10.047. Epub 2015 Nov 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2014)		 577
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2013)		 580
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01870895
Other Study ID Numbers  ICMJE 060-CL-702
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Astellas Pharma Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Astellas Pharma Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP