Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adrenal Insufficiency
Intervention: Hydrocortisone (Drug); Plenadren (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Ulla Feldt-Rasmussen Official(s) and/or principal investigator(s): Ulla Feldt-Rasmussen, MD, DMSc, Principal Investigator, Affiliation: Rigshospitalet, Denmark
Summary
Despite optimized hydrocortisone replacement regimes, many patients with adrenal
insufficiency (AI) suffer from impaired quality of life (QoL). Characteristically, patients
report high fatigue levels at certain times during the day. A modified-release
hydrocortisone has been shown to improve QoL, particularly fatigue, in patients with primary
AI. However, it is unknown, if the same effect can be observed in patients with secondary
AI. Further, no studies have evaluated the effect, taking into account the diurnal variation
of fatigue. A novel survey method termed Ecological Momentary Assessments (EMA) has the
potential to provide reliable measurements of diurnal variations in patient-reported
outcomes, such as fatigue. We will compare the effect of modified-release compared to
conventional hydrocortisone on fatigue in patients with secondary AI due to pituitary
disease, and hereby assess the feasibility of EMA as outcome in future large-scale
randomised clinical trials (RCTs).
Clinical Details
Official title: Effect of Modified-release Compared to Conventional Hydrocortisone on Fatigue, Measured by Ecological Momentary Assessments; a Pilot Study.
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Ecological Momentary Assessment (EMA) fatigue profiles
Secondary outcome: Quality of Life questionnairesSafety (Biochemical parameters, DEXA scan, 24 hour blood pressure and salivary cortisol)
Detailed description:
The study is conducted as an open-label, single-arm, two-period, crossover pilot trial.
Includible patients are observed for 5 weeks on their usual treatment (twice or thrice daily
hydrocortisone). Assessments of QoL, in terms of EMA assessments, to be used as baseline
measurement in the study, are collected for 20 days preceded by a 5 days technology
adaptation phase. Thereafter participants are shifted to modified release hydrocortisone
(Plenadren) once daily (OD), on a dose as per Summary of Product Characteristics (SmPC).
Assessments of QoL to be used as outcome of intervention in the study are performed after
12. 5 weeks after initiation of Plenadren intervention treatment, in order to take into
consideration the period of re-adjustment of the body after the switch from conventional
hydrocortisone to Plenadren. As done at the baseline observation, EMA measurement is
preceded by a five days technology adaptation phase. At the end of the intervention
treatment period, the patients will be shifted to their usual hydrocortisone treatment and
will be followed at the outpatient clinic according to the directives of the clinic.
Biochemical parameters; blood samples, DEXA scan, 24 hour blood pressure and salivary
cortisol, will be assessed at baseline and after 16 weeks, as part of the safety evaluation
of Plenadren.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosed with adrenal insufficiency due to hypopituitarism
- In steady twice or thrice daily (10-40 mg) 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).
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)
Locations and Contacts
Additional Information
Starting date: October 2014
Last updated: November 3, 2014
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