Primary adrenal insufficiency MedDRA version: 20.0 Level: PT Classification code 10052381 Term: Primary adrenal insufficiency System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Plenadren
Product Name: Plenadren
Pharmaceutical Form: Tablet
Trade Name: Cortison
Product Name: Cortison
Pharmaceutical Form: Tablet
Sponsors
Helse Bergen HF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age between 16-80 years. 2) Established PAI according to the diagnostic criteria as specified above. 3) Participants must be recently diagnosed, specifically treated with glucocorticoid replacement therapy for less than 21 days prior to inclusion to secure treatment naivety. 4) Participants must be capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Are the trial subjects under 18? yes Number of subjects for this age range: 8 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Medical conditions 1) Ongoing treatment for active malignant disease 2) Severe hepatic or renal disease 3) Sever psychiatric disease 4) Chronic abuse of alcohol or drug abuse Prior/Concomitant Therapy 5) High dose glucocorticoid therapy for other disease during last three months prior to screening. This includes steroid injections for allergic disease and injections into joints. Local glucocorticoid treatment (inhalations, nasal spray or creams for use on skin) is allowed. 6) Prior/Concurrent Clinical Study Experience 7) Participation in another blinded clinical study involving an investigational medicinal product within 1 month prior to study inclusion Diagnostic Assessments 8) Participants not fulfilling the diagnostic criteria for PAI, as specified above in 5.1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine superiority of Plenadren compared to thrice daily Cortisone for improving overall patient outcome in newly-diagnosed patients with Primary Adrenal Insufficiency. This will be determined by investigating 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 after treatment initiation.;Secondary Objective: Secondary objctives: 1) Differences in clinical markers of cardio-metabolic health in patients receiving Plenadren and conventional thrice daily Cortisone at time of diagnosis and 6 and 12 months after treatment initiation. 2) Differences in hair cortisol concentrations time of diagnosis and in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation. 3) Differences in salivary cortisol day curves in patients receiving Pleandren and conventional Cortisone at 6 and 12 months after treatment initiation. 4) Differences in the urinary cortisol metabolome in patients receiving Pleandren and conventional Cortisone at 6 and 12 months after treatment initiation. 5) Differences in sleep quality in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation. 6) Differences in cognitive function in patients receiving Plenadren and conventional Cortisone at 1, 6 and 12 months after treatment initiation;Primary end point(s): 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 after treatment-initiation in newly diagnosed patients with PAI, using two validated questionnaires: one specific for PAI (AddiQoL-30) and one generic (RAND-36). ;Timepoint(s) of evaluation of this end point: Evaluation will be made at time of diagnosis and at 1, 6, and 12 months after treatment-initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of cardio-metabolic health: • Differences in clinical markers of cardio-metabolic health in patients receiving Plenadren and conventional thrice daily Cortisone at time of diagnosis and 6 and 12 months after treatment initiation. * Blood pressure: systolic blood pressure and diastolic blood pressure * Body weight, waist circumference, and body mass index * Body composition, fat distribution * Levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides * Levels of glucose, insulin, and HOMA index Evaluation of bone health: • Differences in markers of bone health in patients receiving Plenadren and conventional Cortisone at time of diagnosis and 12 months after treatment initiation. * C-terminal telopeptide of type 1 collagen (CTx1) * N-terminal propeptide of type 1 procollagen (P1NP) * Osteocalcin * Bone mineral density and body composition Evaluation of cortisol exposure: • Differences in hair cortisol concentrations at time of diagnosis and 12 months after treatment initiation in patients receiving Plenadren and conventional Cortisone. • Differences in salivary cortisol day curves in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation. • Differences in the urinary cortisol metabolome in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation. Evaluation of sleep: • Differences in sleep quality in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation, using the following instruments: * Epworth sleep questionnaire and sleep diary (https://helse-bergen.no/nasjonal-kompetansetjeneste-for-sovnsykdommer-sovno/sovndagbok-sovno) * Sleep radar Evaluation of cognitive function: • Difference in reaction time and working memory in patients receiving Plenadren and conventional Cortisone at | — |
Countries
Norway
Contacts
Public ContactClinical Trial Unit
Helse Bergen HF
Outcome results
None listed