Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-21 @ 3:40 AM
Study NCT ID:
NCT01870895
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C071315', 'term': 'ramosetron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 577}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-09', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['YM060', 'Ramosetron', 'Diarrhea-predominant Irritable Bowel Syndrome'], 'conditions': ['Diarrhea-predominant Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '26551550', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=060-CL-702', 'label': 'Link to results on Astellas Clinical Study Results Web site'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients satisfying the Rome III Diagnostic Criteria\n2. Patients whose ≥25% of stools were loose or watery and \\<25% of them were hard or lumpy stools\n3. Patients who have abdominal pain or discomfort\n4. 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\n\nExclusion Criteria:\n\n1. Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine\n2. Patients with a history or current evidence of inflammatory bowel disease\n3. Patients with a history or current evidence of colitis ischemic\n4. Patients with concurrent infectious enteritis\n5. Patients with concurrent hyperthyroidism or hypothyroidism\n6. Patients with concurrent active peptic ulcer\n7. 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'}, 'identificationModule': {'nctId': 'NCT01870895', 'briefTitle': 'A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': '060-CL-702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YM060 group', 'interventionNames': ['Drug: YM060']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'YM060', 'type': 'DRUG', 'otherNames': ['ramosetron,', 'Irribow'], 'description': 'oral', 'armGroupLabels': ['YM060 group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Kansai', 'country': 'Japan'}, {'city': 'Kantou', 'country': 'Japan'}, {'city': 'Kyushu', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}