Clinical trial NCT01736423: A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
Official title: A Long Term Study of YM060 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
long term study
Diarrhea-predominant Irritable Bowel Syndrome
Female
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 151
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Monthly responder rate of global assessment of relief of overall IBS symptoms
timeFrame: up to 52 weeks
measure: Monthly responder rate of stool form normalization
timeFrame: up to 52 weeks
measure: Monthly responder rate of global assessment of relief of abdominal pain/discomfort
timeFrame: up to 52 weeks
measure: Monthly responder rate of global assessment of improvement of abnormal bowel habits
timeFrame: up to 52 weeks
measure: Change in weekly average of scores of severity of abdominal pain/discomfort
timeFrame: up to 52 weeks
measure: Change in weekly average of scores of stool form
timeFrame: up to 52 weeks
measure: Change in weekly average of stool frequency
timeFrame: up to 52 weeks
measure: Rate of days without urgency
timeFrame: up to 52 weeks
measure: Rate of days without feeling of incomplete bowel movement
timeFrame: up to 52 weeks
measure: 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
timeFrame: 4, 8, 12, 28 and 52 weeks
Secondary outcomes:
measure: Safety assessed through AEs and clinical laboratory values
timeFrame: up to 52 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, Hayashi K, Akiho H, Nakashima Y, Haruma K. Effect of ramosetron in female patients with irritable bowel syndrome with diarrhea: a phase III long-term study. J Gastroenterol. 2016 Sep;51(9):874-82. doi: 10.1007/s00535-016-1165-5. Epub 2016 Jan 22.