Clinical trial NCT01870895: A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)
Official title: A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea-predominant Irritable Bowel Syndrome
Keywords: YM060
Ramosetron
Diarrhea-predominant Irritable Bowel Syndrome
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 577
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Monthly responder rate of global assessment of relief of overall IBS symptoms at final point
timeFrame: Up to 12 weeks
measure: Monthly responder rate of stool form normalization at final point
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Monthly responder rate of global assessment of relief of abdominal pain/discomfort
timeFrame: Up to 12 weeks
measure: Monthly responder rate of global assessment of improvement of abnormal bowel habits
timeFrame: Up to 12 weeks
measure: Change in weekly average scores of severity of abdominal pain/discomfort
timeFrame: Up to 12 weeks
measure: Change in weekly average scores of stool form
timeFrame: Up to 12 weeks
measure: Safety assessment of YM060
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.