[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551434":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":39,"locations":47,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":25,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"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,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Waterloo","Iowa","50701","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-92.34296,42.49276,{"lat":59,"lon":58},[62],{"name":37,"role":41,"phone":63,"phoneExt":25,"email":46},"319-888-8275",{"type":65,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[67],{"name":68,"class":69},"Ardelyx","INDUSTRY","100551434","phase-2-tenapanor-in-synucleinopathy-related-constipation-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":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation",[88,89],"Synucleinopathy","Parkinson's Disease",[91,92,93,94],"tenapanor","synucleinopathy","Parkinson's disease","constipation","2025-02-06",{"date":97,"type":98},"2025-02-10","ACTUAL",{"date":100,"type":98},"2025-01-01",{"date":102,"type":82},"2027-03",{"name":5,"class":6},1]