Clinical trial • Phase IV • Endocrinology|Rare Disease
Hydrocortisone for Primary adrenal insufficiency
Phase IV trial of Hydrocortisone for Primary adrenal insufficiency.
Overview
- Trial Therapeutic Area
- Endocrinology|Rare Disease
- Trial Disease
- Primary adrenal insufficiency
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 05-07-2024
- First CTIS Authorization Date
- 07-08-2024
Trial design
Randomised, open-label, cortison 25 mg tabletter (cortisone) — 25 mg tablets, oral; maximum daily dose reported as 60 mg. comparator arm vs plenadren; specific dosing schedule not further specified in source.-controlled Phase IV trial across 14 sites in Norway.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Cortison 25 mg tabletter (cortisone) — 25 mg tablets, oral; maximum daily dose reported as 60 mg. Comparator arm vs Plenadren; specific dosing schedule not further specified in source.
- Real World Control
- Yes
- Target Sample Size
- 50
- Trial Duration For Participant
- 365
Eligibility
Recruits 50 paediatric patients.
- Pregnancy Exclusion
- Current pregnancy, and if the participant plan to become pregnant during the 12 months of study participation.
- Vulnerable Population
- isVulnerablePopulationSelected: false. Inclusion criteria state: "Participants must be capable of giving signed informed consent". No information provided on assent or parental consent for minors; no vulnerable-population-specific consent procedures described in the source.
Inclusion criteria
- {"criterion_text":"- Age 16-80 years\n- Established PAI according to the diagnostic criteria as specified above.\n- Participants must be recently diagnosed, specifically treated with glucocorticoid replacement therapy for less than 31 days prior to inclusion to secure treatment naivety.\n- Women of childbearing potential (WOCBP) must have a negative pregnancy test performed at the time of screening.\n- Participants must be capable of giving signed informed consent"}
Exclusion criteria
- {"criterion_text":"- High dose glucocorticoid therapy for other disease during last three months prior to screening.\n- Ongoing treatment for active malignant disease.\n- Severe hepatic or renal disease.\n- Sever psychiatric disease.\n- Chronic abuse of alcohol or drug abuse.\n- Current pregnancy, and if the participant plan to become pregnant during the 12 months of study participation.\n- Known hypersensitivity to the active substance or any of the excipients.\n- Participation in another blinded clinical study involving an investigational medicinal product within 1 month prior to study inclusion."}
Endpoints
Primary endpoints
- {"endpoint_text":"- HRQoL score.","definition_or_measurement_approach":"Differences in health-related quality of life (HRQoL) scores in patients receiving Plenadren and conventional Cortisone at time of diagnosis and 1, 6, and 12 months."}
Secondary endpoints
- {"endpoint_text":"- Blood pressure, body weight, waist circumference, body mass index, cholesterols, glucose, insulin, HOMA index.","definition_or_measurement_approach":"Direct clinical and laboratory measurements (blood pressure, anthropometrics, blood tests for lipids, glucose, insulin and HOMA index)."}
- {"endpoint_text":"- Hair cortisol level, Salivary cortisol day curves, 24 h urine cortisol and metabolites.","definition_or_measurement_approach":"Biomarker assays including hair cortisol, serial salivary cortisol day curves, and 24-hour urine cortisol/metabolite measurement."}
- {"endpoint_text":"- Sleep diary, actigraphy, sleep radar.","definition_or_measurement_approach":"Patient-reported sleep diary and objective sleep monitoring using actigraphy and sleep radar devices."}
- {"endpoint_text":"- Cognitive testing and biomarker for brain plasticity (BDNF) in serum.","definition_or_measurement_approach":"Standardized cognitive tests and measurement of serum BDNF as a biomarker."}
- {"endpoint_text":"- Bone mineral density, body composition and bone markers","definition_or_measurement_approach":"DXA or other bone density assessment, body composition measures and laboratory bone marker assays."}
- {"endpoint_text":"- Adverse events, Serious adverse events, Adrenal crisis symptoms and treatment.","definition_or_measurement_approach":"Recording and reporting of adverse events and serious adverse events per standard pharmacovigilance; specific collection of adrenal crisis events and their treatments."}
Recruitment
- Registry Or Advocacy Recruitment
- True, registry names not specified in source
- Planned Sample Size
- 50
- Recruitment Window Months
- 42
- Consent Approach
- Participants must be capable of giving signed informed consent (inclusion criterion). A subject information and informed consent form document is listed (L1_ SIS and ICF all participants). No details in the source about assent, parental consent for minors (16-17 years), or languages of consent documents.
Methods
- Registry-based recruitment (study described as 'registry-based' in the public full title) targeting patients with newly diagnosed primary adrenal insufficiency.
- Site-based recruitment at participating hospitals and clinics across Norway (participating hospital sites listed in CTIS).
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 50
Norway
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 12-11-2025
- Processing Time Days
- 484
- Number Of Sites
- 14
- Number Of Participants
- 50
Sites
- Site Name
- Sykehuset Oestfold HF Kalnes
- Department Name
- Department of Medicine
- Contact Person Name
- Margrethe Svendsen
- Contact Person Email
- margrethe.svendsen@so-hf.no
- Site Name
- Stavanger University Hospital HF
- Department Name
- Department of Medicine
- Contact Person Name
- Ann-Elin Meling Stokland
- Contact Person Email
- ann-elin.meling.stokland@sus.no
- Site Name
- Helse Bergen HF
- Department Name
- Department of Medicine
- Contact Person Name
- Eystein Husebye
- Contact Person Email
- eyhu@helse-bergen.no
- Site Name
- Sykehuset I Vestfold HF
- Department Name
- Department of Medicine
- Contact Person Name
- Aleksandra Debowska
- Contact Person Email
- Aleksandra.debowska@siv.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Medicine
- Contact Person Name
- Anders Jørgensen
- Contact Person Email
- andjo@ous-hf.no
- Site Name
- Helse Moere Og Romsdal HF
- Department Name
- Department of Medicine
- Contact Person Name
- Marthe Rensvik
- Contact Person Email
- marthe.landsverk.rensvik@helse-mr.no
- Site Name
- Sykehuset Innlandet HF
- Department Name
- Department of Medicine
- Contact Person Name
- Trine Finnes
- Contact Person Email
- Trine.E.Finnes@sykehuset-innlandet.no
- Site Name
- Akershus University Hospital
- Department Name
- Department of Medicine
- Contact Person Name
- Ingrid Nermoen
- Contact Person Email
- Ingrid.Nermoen@ahus.no
- Site Name
- Helse Fonna HF
- Department Name
- Department of Medicine
- Contact Person Name
- Ida Kloster
- Contact Person Email
- ida.kloster@helse-fonna.no
- Site Name
- Universitetssykehuset Nord-Norge HF
- Department Name
- Department of Medicin
- Contact Person Name
- Simon Kildal
- Contact Person Email
- simon.kildal@unn.no
- Site Name
- Sorlandet Sykehus HF
- Department Name
- Department of Medicine
- Contact Person Name
- Aneta Tomkowicz
- Contact Person Email
- Aneta.Ewa.Tomkowicz@sshf.no
- Site Name
- Helse Nord-Trondelag HF
- Department Name
- Department of Medicine
- Contact Person Name
- Dag-Eirik Sørmo
- Contact Person Email
- dag-eirik.sormo@helse-nordtrondelag.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Department of Medicine
- Contact Person Name
- Hallvard Singsås
- Contact Person Email
- hallvard.singsas@stolav.no
- Site Name
- Vestre Viken HF
- Department Name
- Department of Medicine
- Contact Person Name
- Stina Sollid
- Contact Person Email
- STTHSO@vestreviken.no
Sponsor
Primary sponsor
- Full Name
- Helse Bergen HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- Plenadren 20 mg modified-release tablets
- Active Substance
- Hydrocortisone
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketed (marketing authorisation present; EU MA PRD3796058)
- Starting Dose
- 20 mg (product strength)
- Frequency
- Not specified (maximum daily dose reported as 60 mg)
- Maximum Dose
- 60 mg
- Investigational Product Name
- Cortison 25 mg tabletter
- Active Substance
- Cortisone
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketed (marketing authorisation present)
- Starting Dose
- 25 mg (product strength)
- Frequency
- Not specified (maximum daily dose reported as 60 mg)
- Maximum Dose
- 60 mg
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