[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551434":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":39,"locations":47,"responsibleParty":63,"collaborators":65,"id":69,"slug":25,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":25,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Cedar Valley Digestive Health Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tenapanor","EXPERIMENTAL","Tenapanor 50 mg orally twice daily for 12 weeks",[13],"Drug: Tenapanor",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo orally twice daily for 12 weeks",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Inhibitor of NHE3",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo drug",[15],[30,33,36],{"name":31,"affiliation":5,"role":32},"Richard A. Manfready, MD, AM, FACP","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":5,"role":35},"Ravindra Mallavarapu, MD","STUDY_CHAIR",{"name":37,"affiliation":5,"role":38},"Harichandana Punukula, PharmD, MS","STUDY_DIRECTOR",[40,44],{"name":31,"role":41,"phone":42,"phoneExt":25,"email":43},"CONTACT","(319) 235-5390","rman@alum.mit.edu",{"name":37,"role":41,"phone":45,"phoneExt":25,"email":46},"319-888-8270","hpunukula@cvmspc.com",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Waterloo","Iowa","50701","United States",{"type":55,"coordinates":56},"Point",[57,58],-92.34296,42.49276,{"lat":58,"lon":57},[61],{"name":37,"role":41,"phone":62,"phoneExt":25,"email":46},"319-888-8275",{"type":64,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[66],{"name":67,"class":68},"Ardelyx","INDUSTRY","100551434",false,"NCT06460038","Tenapanor in Synucleinopathy-Related Constipation","Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation","Inclusion Criteria\n\n1. Age 50-89 years.\n2. Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria.\n3. Average weekly stool frequency of ≤5 spontaneous bowel movements (SBMs) and ≤2 complete spontaneous bowel movements (CSBMs) over the past 6 months. These criteria will be verified during a 2-week screening period.\n4. Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period.\n5. Agreement to use contraception, if applicable.\n\nExclusion Criteria\n\n1. Functional diarrhea or IBS-D\u002FM based on Rome IV Criteria.\n2. Symptomatic structural GI abnormalities or inflammatory bowel disease.\n3. Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine \\>2mg\u002Fdl) dysfunction.\n4. Pregnancy or lactation.\n5. Diagnosis of primary dyssynergic defecation by anorectal manometry.","ALL","50 Years","89 Years",{"count":79,"type":80},30,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation",[86,87],"Synucleinopathy","Parkinson's Disease",[89,90,91,92],"tenapanor","synucleinopathy","Parkinson's disease","constipation","2025-02-06",{"date":95,"type":96},"2025-02-10","ACTUAL",{"date":98,"type":96},"2025-01-01",{"date":100,"type":80},"2027-03",{"name":5,"class":6},1]