- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02282150
Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism (PlenadrEMA)
February 21, 2017 updated by: Ulla Feldt-Rasmussen
Effect of Modified-release Compared to Conventional Hydrocortisone on Fatigue, Measured by Ecological Momentary Assessments; a Pilot Study.
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Conventional vs modified hydrocortisone;
5 weeks of conventional hydrocortisone followed by 16 weeks of modified-release hydrocortisone (Plenadren)
|
Usual hydrocortisone dosage regimen; 10-40 mg hydrocortisone administered twice or thrice daily for 5 weeks
10-40 mg modified-release hydrocortisone in tablets, once a day for 16 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ecological Momentary Assessment (EMA) fatigue profiles
Time Frame: 25 days during conventional hydrocortisone treatment and for 25 days during Plenadren (intervention) treatment
|
Differences and variability of standard treatment vs. modified release hydrocortisone EMA fatigue profiles
|
25 days during conventional hydrocortisone treatment and for 25 days during Plenadren (intervention) treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life questionnaires
Time Frame: At baseline and after 16 weeks of Plenadren (intervention) treatment
|
Fatigue Impact Scale (FIS), AD-specific quality-of-life questionnaire (AddiQol) and the Short Form Health Survey (SF-36)
|
At baseline and after 16 weeks of Plenadren (intervention) treatment
|
Safety (Biochemical parameters, DEXA scan, 24 hour blood pressure and salivary cortisol)
Time Frame: At baseline and after 16 weeks of Plenadren (intervention) treatment
|
Biochemical parameters, DEXA scan, 24 hour blood pressure and salivary cortisol
|
At baseline and after 16 weeks of Plenadren (intervention) treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Anticipated)
November 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
October 26, 2014
First Submitted That Met QC Criteria
November 3, 2014
First Posted (Estimate)
November 4, 2014
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 21, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLEN-EMA-hypo
- 2014-002039-32 (EudraCT Number)
- H-1-2014-073 (Other Identifier: Health Research Ethics in Capital Region of Denmark)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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