[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05905926":3,"trial-entities:NCT05905926":266,"trial-summary:NCT05905926":270},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":52,"locations":55,"central_contacts":259,"overall_officials":260,"references":264,"see_also_links":265},"NCT05905926","TEN-01-306","Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C","An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 6 to Less Than 18 Years Old","ENROLLING_BY_INVITATION","2031-10","2026-06","2026-06-04","2023-02-17","Ardelyx","INDUSTRY",false,"Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.","Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study.\n\nPatients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.",[19],"Irritable Bowel Syndrome With Constipation (IBS-C)",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"PHASE3",{"count":26,"type":27},150,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Tenapanor","Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID",[31],[35],"Ibsrela",[37,41],{"measure":38,"description":39,"timeFrame":40},"Safety Measure Assessment (Adverse Event)","Incidence of AEs, SAEs and drug related adverse events","40 weeks",{"measure":42,"description":43,"timeFrame":40},"Safety Measure Assessment (ECG)","Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval)",[],"ALL","6 Years","18 Years",{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"Inclusion Criteria:\n\n1. ≥6 and \\\u003C18 years old at enrollment of either parent study\n2. Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator\n3. Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence).\n4. Subject is ambulatory\n5. Written informed consent by parent\u002Fguardian\u002F Legally Authorized Representative (LAR) and a willingness of both subject and parent\u002Fguardian\u002FLAR to participate in the study as it is described\n\nExclusion Criteria:\n\n1. Patient discontinued prematurely from the parent study.\n2. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy\n3. Pregnant or lactating women\n4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol",[53,54],"CHILD","ADULT",[56,65,73,81,88,95,102,109,117,125,133,141,149,157,164,172,179,186,194,200,208,216,223,230,237,244,251],{"facility":57,"city":58,"state":59,"zip":60,"country":61,"geoPoint":62},"G & L Research, LLC","Foley","Alabama","36535","United States",{"lat":63,"lon":64},30.40659,-87.6836,{"facility":66,"city":67,"state":68,"zip":69,"country":61,"geoPoint":70},"Advanced Research Center, Inc.","Anaheim","California","92805",{"lat":71,"lon":72},33.83529,-117.9145,{"facility":74,"city":75,"state":76,"zip":77,"country":61,"geoPoint":78},"Prohealth Research Center","Doral","Florida","33166",{"lat":79,"lon":80},25.81954,-80.35533,{"facility":82,"city":83,"state":76,"zip":84,"country":61,"geoPoint":85},"I.H.S. Health, LLC","Kissimmee","34741",{"lat":86,"lon":87},28.30468,-81.41667,{"facility":89,"city":90,"state":76,"zip":91,"country":61,"geoPoint":92},"Valencia Medical and Research Center","Miami","33165",{"lat":93,"lon":94},25.77427,-80.19366,{"facility":96,"city":97,"state":76,"zip":98,"country":61,"geoPoint":99},"Orlando Health, Inc.- APH Center for Digestive Health and Nutrition","Orlando","32806",{"lat":100,"lon":101},28.53834,-81.37924,{"facility":103,"city":104,"state":76,"zip":105,"country":61,"geoPoint":106},"Florida Pharmaceutical Research and Associates, Inc.","South Miami","33143",{"lat":107,"lon":108},25.7076,-80.29338,{"facility":110,"city":111,"state":112,"zip":113,"country":61,"geoPoint":114},"OSF Saint Francis Medical Center","Peoria","Illinois","61637",{"lat":115,"lon":116},40.69365,-89.58899,{"facility":118,"city":119,"state":120,"zip":121,"country":61,"geoPoint":122},"Riley Children's Health","Indianapolis","Indiana","46202",{"lat":123,"lon":124},39.76838,-86.15804,{"facility":126,"city":127,"state":128,"zip":129,"country":61,"geoPoint":130},"Maine Health","Portland","Maine","04102",{"lat":131,"lon":132},43.65737,-70.2589,{"facility":134,"city":135,"state":136,"zip":137,"country":61,"geoPoint":138},"Mankato Clinic\u002F Javara Research Ltd","Mankato","Minnesota","56001",{"lat":139,"lon":140},44.15906,-94.00915,{"facility":142,"city":143,"state":144,"zip":145,"country":61,"geoPoint":146},"Boys Town National Research Hospital","Boys Town","Nebraska","68010",{"lat":147,"lon":148},41.26111,-96.13196,{"facility":150,"city":151,"state":152,"zip":153,"country":61,"geoPoint":154},"SUNY Downstate Medical Center","Brooklyn","New York","11203",{"lat":155,"lon":156},40.6501,-73.94958,{"facility":158,"city":159,"state":152,"zip":160,"country":61,"geoPoint":161},"Advantage Clinical Trials","The Bronx","10467",{"lat":162,"lon":163},40.84985,-73.86641,{"facility":165,"city":166,"state":167,"zip":168,"country":61,"geoPoint":169},"Atrium Health","Charlotte","North Carolina","28203",{"lat":170,"lon":171},35.22709,-80.84313,{"facility":173,"city":174,"state":167,"zip":175,"country":61,"geoPoint":176},"Duke University School of Medicine","Durham","27705",{"lat":177,"lon":178},35.99403,-78.89862,{"facility":180,"city":181,"state":167,"zip":182,"country":61,"geoPoint":183},"Wilmington Health","Wilmington","28401",{"lat":184,"lon":185},34.23556,-77.94604,{"facility":187,"city":188,"state":189,"zip":190,"country":61,"geoPoint":191},"Frontier Clinical Research, LLC","Scottdale","Pennsylvania","15683",{"lat":192,"lon":193},40.10035,-79.58698,{"facility":187,"city":195,"state":189,"zip":196,"country":61,"geoPoint":197},"Smithfield","15478",{"lat":198,"lon":199},39.80313,-79.80783,{"facility":201,"city":202,"state":203,"zip":204,"country":61,"geoPoint":205},"Prisma Health Children's Hospital","Greenville","South Carolina","29615",{"lat":206,"lon":207},34.85262,-82.39401,{"facility":209,"city":210,"state":211,"zip":212,"country":61,"geoPoint":213},"Advance Clinical Trial PLLC","Abilene","Texas","79606",{"lat":214,"lon":215},32.44874,-99.73314,{"facility":217,"city":218,"state":211,"zip":219,"country":61,"geoPoint":220},"Maspons Pediatric Gastro","El Paso","79902",{"lat":221,"lon":222},31.75872,-106.48693,{"facility":224,"city":225,"state":211,"zip":226,"country":61,"geoPoint":227},"Texas Digestive Specialists","Harlingen","78550",{"lat":228,"lon":229},26.19063,-97.6961,{"facility":231,"city":232,"state":211,"zip":233,"country":61,"geoPoint":234},"AIM Trials, LLC","Plano","75093",{"lat":235,"lon":236},33.01984,-96.69889,{"facility":238,"city":239,"state":211,"zip":240,"country":61,"geoPoint":241},"Sun Research Institute","San Antonio","78215",{"lat":242,"lon":243},29.42412,-98.49363,{"facility":245,"city":246,"state":211,"zip":247,"country":61,"geoPoint":248},"Pioneer Research Solutions Inc","Sugar Land","77479",{"lat":249,"lon":250},29.61968,-95.63495,{"facility":252,"city":253,"state":254,"zip":255,"country":61,"geoPoint":256},"Frontier Clinical Research","Kingwood","West Virginia","26537",{"lat":257,"lon":258},39.47176,-79.68339,[],[261],{"name":262,"affiliation":13,"role":263},"Jocelyn Tabora","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":267,"biomarkers":269},[268],"Irritable Bowel Syndrome",[],{"nct_id":4,"found":15,"summary":271,"prompt_version":271},null]