Endpoint Hierarchy EndpointConceptsEndpoint TypePrimary CompanyOrganizationRepresentatives AllerganRobyn T Carson MPH CoChair Steven J Shiff MDIronwood PharmaceuticalsIncAndrew I Damokosh ID: 938599
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Working Group ParticipantsBackgroundRationale for Irritable Bowel Syndrome (IBS) Working Group (WG) IBS is one of the most common gastrointestinal (GI) disordersIBS lacks a standard “fitforpurpose” PRO instrument for assessing important patientexperienced signs and symptoms of IBSPRO Consortium member firm representatives and FDA advisors identified IBS as a priority area for the development of a PRO instrumentGoal of the IBS WGTo develop three PRO measures for patientreported symptoms in IBS with constipation (IBSC), IBS with diarrhea (IBSD), and IBS with mixed symptoms (IBSM) for use in clinical trials as a primary endpoint measure to establish treatment benefitConcept of InterestIBS sign and symptom severityTargeted Labeling LanguageeDrug Xis indicated in adults for the treatment of symptoms associated with irritable bowel syndrome [with constipation (IBSC), with diarrhea (IBSD), or mixed (IBSM)] Endpoint Hierarchy EndpointConcept(s)Endpoint TypePrimary Company/OrganizationRepresentatives AllerganRobyn T. Carson, MPH (CoChair); Steven J. Shiff, MDIronwood Pharmaceuticals,Inc.Andrew I. Damokosh, PhD (CoChair)Takeda Pharmaceuticals InternationalNote: Takeda provided funding for the IBS WG but is no longer an active participant in it. Other ParticipantAffiliationCeciel T. RookerInternational Foundationfor Gastrointestinal Disorders FFGD)Expert Panel MembersAffiliationLin Chang, MDUniversity of California,Los AngelesWilliam D. Chey, MD Abdominal Pain *, Abdominal Discomfort *, Abdominal Bloating *, Stool Consistency *, StoolFrequency *, Incomplete BMs *, Recurrent BMs Abdominal Cramping Straining Abdominal Symptoms Bowel MovementRelated SymptomsMeasures developed for each subtype:Diary for Irritable Bowel Syndrome SymptomsC (DIBSSC) for constipation predominantDiary for Irritable Bowel Syndrome SymptomsD (DIBSSD) for diarrhea predominantDiary for Irritable Bowel Syndrome SymptomsM (DIBSSM) for mixed symptomsCore Items: Abdominal symptoms and bowel movementrelated signs/symptomsRecall Period: Eventdriven and 24hour (end of day)Response Options: Verbal rating scales, bivariate response, 11point numeric rating scalesData Collection Mode: Handheld smartphone device used for quantitative pilot study MilestoneExpectedDateCompleted DateBriefing package submission to FDA (final Cognitive Interview Report and updated Briefing Document)AUG 2014Received FDA response and approval to conduct quantitative pilot studyDEC 2014Quantitative pilot study protocol and quantitative analysis plan (QAP) submission to FDADEC 2015Full Qualification Package submission for DIBSSto FDA DEC 2018Responded to Information Request 1 received from FDA on February 14, 2019 MAR 2019Responded to Information Request 2 received from FDA on June 6, DEC 2019Responded to Information Request 3 received from FDA on March 14, MAR 2020Full Qualification Package submission for DIBSSto FDATBDFull Qualification Package submission for DIBSSto FDATBDMeasuresDiary for Irritable Bowel Syndrome Symptoms (C, D, M)Highlights