[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100344143":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":60,"collaborators":11,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Federico II University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Dual-release hydrocortisone","EXPERIMENTAL",null,[13,14],"Drug: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone)","Drug: Dual release hydrocortisone (plenadren)",{"label":16,"type":17,"description":11,"interventionNames":18},"Conventional glucocorticoids","ACTIVE_COMPARATOR",[13],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone)","Treatment of congenital adrenal hyperplasia",[16,9],{"type":21,"name":26,"description":23,"armGroupLabels":27,"otherNames":11},"Dual release hydrocortisone (plenadren)",[9],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Rosario Pivonello, M.D., PhD, Professor","CONTACT","+390817464983","rosario.pivonello@unina.it",[35],{"facility":5,"status":36,"city":37,"state":11,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Naples","80131","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],14.26811,40.85216,{"lat":45,"lon":44},[48,50,53,56,58],{"name":49,"role":31,"phone":32,"phoneExt":11,"email":33},"Rosario Pivonello, MD,PhD,Professor",{"name":51,"role":52,"phone":11,"phoneExt":11,"email":11},"Rosario Pivonello, MD, PhD, Professor","PRINCIPAL_INVESTIGATOR",{"name":54,"role":55,"phone":11,"phoneExt":11,"email":11},"Chiara Simeoli, MD","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":11,"phoneExt":11,"email":11},"Maria Cristina De Martino, MD, PhD",{"name":59,"role":55,"phone":11,"phoneExt":11,"email":11},"Rosario Ferrigno, MD",{"type":52,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Prof. Rosario Pivonello","Full Professor","100344143","phase-4-congenital-adrenal-hyperplasia-once-daily-hydrocortisone-treatment-100344143",false,"NCT03760835","Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment","Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment","CareOnTIME","Inclusion Criteria:\n\n* males and females aged \\>18 years;\n* established diagnosis of adrenal insufficiency in congenital adrenal hyperplasia due to 21-hydroxylase deficiency;\n* stably treated with conventional glucocorticoids, available to change their regimen according to random allocation\n* written informed consent\u002Fassent to participate in the study in compliance with local regulations.\n\nExclusion Criteria:\n\n* clinical or laboratory signs of severe cerebral, respiratory, hepatobiliary or pancreatic diseases, renal dysfunction, gastrointestinal emptying, or motility disturbances (i.e. chronic diarrhea), significant psychiatric illnesses;\n* history of\u002For current alcohol and\u002For drug abuse;\n* night shift workers;\n* underlying diseases that could necessitate treatment with glucocorticoids;\n* therapies with hepatic enzyme induction drugs interfering with glucocorticoid kinetics, or immunosuppressive steroid therapy;\n* patients with a documented intolerance\u002Fknown hypersensitivity to dual release hydrocortisone;\n* vulnerable populations, such as elderly, cancer patients, pregnant and lactating women;\n* history of non-compliance to medical regimens, or potentially unreliable patients","ALL","18 Years",{"count":74,"type":75},150,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","This is a controlled, open study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on clinical, anthropometric parameters, metabolic syndrome, hormonal profile, bone status, quality of life, reproductive, sexual and psychological functions and treatment compliance in patients affected by congenital adrenal hyperplasia due to 21 OH deficiency.",[81],"Congenital Adrenal Hyperplasia",[83,84,85],"congenital adrenal hyperplasia","glucocorticoid treatment","dual release hydrocortisone","2025-09-10",{"date":88,"type":89},"2025-09-16","ACTUAL",{"date":91,"type":89},"2016-08-11",{"date":93,"type":75},"2027-12-31",{"name":5,"class":6},1]