Secondary adrenal insufficiency due to hypopituitarism MedDRA version: 20.0 Level: LLT Classification code 10052382 Term: Secondary adrenal insufficiency System Organ Class: 100000004860
Conditions
Interventions
Trade Name: Plenadren 5 mg modified-release tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentra
Sponsors
Rigshospitalet, Copenhagen University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 or older - Diagnosed with adrenal insufficiency due to hypopituitarism - In steady twice or thrice daily hydrocortisone replacement treatment - Written informed consent - For women: Use of reliable methods of contraception in clinical trials in accordance with the definition by the Danish Health and Medicines Authority; intrauterine devices or hormonal methods (oral contraceptives, contraceptive implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Pregnancy - Breast feeding - Acromegaly - Cushing’s Disease - Diabetes Mellitus - Other major confounding disease - Known or expected hypersensitivity to any of the excipients - Lack of compliance (attendance and medication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate feasibility of EMA assessments as outcome in future large-scale randomized clinical trials (RCT) of modified release hydrocortisone. To quantify the variability of such measurements in patients with adrenal insufficiency due to hypopituitarism and to acquire an estimate of the size of the expected difference in scores; both of which are required for sample size calculations. To identify the best suited outcome for an RCT, i.e. the most informative with the least participant burden; i.e. the most responsive, brief summary measure. ;Secondary Objective: Not applicable;Primary end point(s): Assessment of diurnal variations of fatigue by Ecological Momentary Assessment (EMA) The standardized, generally validated fatigue instrument Multidimenisonal Fatigue Inventory (MFI-20; see Appendix #2) will be adapted to EMA. Four times daily (morning, mid-day, afternoon, evening), at random time-points within pre-specified time-slots, the participants are prompted to respond to eight brief questions from the MFI20. Four from the General Fatigue scale are administered every day during the observation period and four from one of the four remaining scales (Physical Fatigue, Mental Fatigue, Reduced Activity and Reduced Motivation). ;Timepoint(s) of evaluation of this end point: Outcome measures are collected for 20 days, performed 12.5 weeks after initiation of Plenadren intervention treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Fatigue Impact Scale (FIS), AddiQoL and SF-36 questionnaires Safety ;Timepoint(s) of evaluation of this end point: FIS, AddiQol and SF-36 questionnaires will be administered at baseline (1st visit; during conventional hydrocortisone treatment) and at the last visit (after 16 weeks of modified-release hydrocortison treatment) Likewise, safety assessment, in terms of blood samples, DEXA scan, 24 hr blood pressure, salivary cortisol, will be done at baseline (1st visit; during conventional hydrocortisone treatment) and at the last visit (after 16 weeks of modified-release hydrocortison treatment). | — |
Countries
Denmark
Contacts
Public ContactPlenadrEMA Study Information
Copenhagen University Hospital, Rigshospitalet
Outcome results
None listed