[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578351":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":11,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cystic fibrosis patients with CF-related constipation","EXPERIMENTAL",null,[13],"Drug: Tenapanor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Tenapanor","CF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks.",[9],[21],{"name":22,"affiliation":5,"role":23},"Christoher D Velez, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Chloe Butzel, BA","CONTACT","6176437088","cbutzel@mgh.harvard.edu",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-71.05977,42.35843,{"lat":42,"lon":41},[45,46],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},{"name":47,"role":23,"phone":11,"phoneExt":11,"email":11},"Christopher Velez, MD",{"type":23,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Christopher Velez","Principal Investigator",[52],{"name":53,"class":54},"Ardelyx","INDUSTRY","100578351","phase-3-assessing-tenapanor-as-a-treatment-of-cf-related-constipation-100578351",false,"NCT06810167","Assessing Tenapanor as a Treatment of CF-related Constipation.","An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.","Inclusion Criteria:\n\n1. Having confirmed cystic fibrosis (either by sweat chloride or genetic testing)\n2. Meeting criteria for CFrC\n\n   Must include 2 of the following, with or without abdominal pain for at least 3 months, with symptom onset at least 6-months prior:\n   * Straining in at least 25% of defecations\n   * Bristol Stool Scale 1-2 more than 25% of defecations (change in stool form)\n   * Sensation of incomplete evacuation more than 25% of defecations\n   * Sensation of anorectal obstruction\u002Fblockage more than 25% of defecations\n   * Manual disimpaction\u002Fmanipulation of pelvic floor to facilitate more than 25% of defecations\n   * Fewer than 3 spontaneous bowel movements weekly (change in stool frequency)\n   * Loose stools rarely present without the use of laxatives\n3. Willingness to avoid major dietary or lifestyle changes during study.\n\nExclusion Criteria:\n\n1. Use of any antibiotic to treat infection within the 4-weeks prior to study initiation (stable azithromycin dosed 3-times weekly for lung function is to be allowed)\n2. Inability to discontinue standing bowel regimen (including fiber, stool softener, as well as either osmotic or stimulant laxative, pro-kinetic serotonergic agents, or other therapy) 2-weeks prior to study drug initiation (with ability to use osmotic laxative therapy as rescue therapy only).\n3. Severe CFrC as determined by study team\n4. Prior tenapanor usage\n5. Hospitalization within 4-weeks prior to study initiation.\n6. DIOS within 4-weeks prior to study initiation.\n7. Other known\u002Fsuspected mechanical obstruction","ALL","18 Years","75 Years",{"count":66,"type":67},25,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic fibrosis-related constipation (CFrC) in CF patients. Participants will ingest one 50 mg tablet of tenapanor, twice daily, for a 4-week treatment period. They will also complete three questionnaires, the PAC-SYM, PAC-QoL, and IBS-SSS, and daily diaries to characterize GI symptom burden and spontaneous bowel movement (SBM) frequency.",[73,74],"Cystic Fibrosis","Constipation",[74,73,76],"CFrC","2026-03-17",{"date":79,"type":80},"2026-03-18","ACTUAL",{"date":82,"type":80},"2025-06-01",{"date":84,"type":67},"2027-06-30",{"name":5,"class":6},1]