[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549550":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":47,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":81,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Chewable Tablet Group","EXPERIMENTAL","Group of patients receiving a new hydrocortisone formulation in the form of chewable tablets. Patients in this group will take the 3D printed chewable tablets orally for a duration of three months.",[13],"Drug: 3D printed chewable formulation of hydrocortisone",{"label":15,"type":16,"description":17,"interventionNames":18},"Oral Suspension Group","ACTIVE_COMPARATOR","Group of patients receiving the standard hydrocortisone formulation in the form of an oral solution. Patients in this group will orally ingest the solution over a period of three months.",[19],"Drug: Oral suspension of hydrocortisone",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","3D printed chewable formulation of hydrocortisone","Administration of a novel hydrocortisone formulation provided as chewable tablets. Each tablet, manufactured with a volume dosing device (3D printer), contains a precise dosage of hydrocortisone.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Oral suspension of hydrocortisone","Administration of a standard hydrocortisone oral suspension. The solution, based on simple syrup, contains 1mg of hydrocortisone per milliliter.",[15],[32],{"name":33,"affiliation":34,"role":35},"Hospital Universitari Vall d'Hebron","Hospital Vall d'Hebron","STUDY_CHAIR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Carlos Javier Parramón Teixidó","CONTACT","+3492746017","6017","carlosjavier.parramon@vallhebron.cat",{"name":5,"role":39,"phone":44,"phoneExt":45,"email":46},"+34934894010","4010","ceic@vhir.org",[48],{"facility":33,"status":26,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Barcelona","08035","Spain","ES",{"type":54,"coordinates":55},"Point",[56,57],2.15899,41.38879,{"lat":57,"lon":56},[60],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":42},{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100549550","phase-4-tolerability-and-acceptance-of-two-oral-hydrocortisone-compounding-formulation-for-pediatrics-100549550",false,"NCT06435481","Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics","Inclusion Criteria:\n\n* Outpatients of both sexes, ≥ 6 years old without swallowing problems and up to 17 years old, at the time of signing the informed consent document by parent(s) or guardian(s) and\u002For patients.\n* Diagnosis of adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency).\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the excipients in the formulation of hydrocortisone.\n* Any disorder or situation (decompensation) that, in the opinion of the investigating physician, poses a risk of non-compliance with the treatment.","ALL","6 Years","18 Years",{"count":73,"type":74},35,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","The study aims to evaluate the tolerability and acceptance of two compounded formulations of hydrocortisone prepared in the Vall d'Hebron University Hospital (VHUH) Pharmacy Service: one, an oral suspension and the other, chewable tablets prepared using a volume dosing device (M3DIMAKER 3D printer). The main goal is to enhance patient care and adherence among pediatric patients.\n\nThis prospective, experimental study employs a randomized, crossover design and will take place solely at VHUH. Approximately 25-30 eligible patients diagnosed with adrenal hyperplasia, isolated primary adrenal insufficiency, or panhypopituitarism will be recruited. Each patient will receive each hydrocortisone formulation for a period of 3 months, totaling 6 months of treatment per patient. All patients will receive the medication at their usual dose and both formulations to assess tolerability and acceptance.",[80],"Adrenal Insufficiency","NOT_YET_RECRUITING","2024-05-24",{"date":84,"type":85},"2024-05-30","ACTUAL",{"date":87,"type":74},"2024-09",{"date":89,"type":74},"2026-09",{"name":5,"class":6},1]