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Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism (PlenadrEMA)

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ClinicalTrials.gov Identifier: NCT02282150
Recruitment Status : Enrolling by invitation
First Posted : November 4, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark

Brief 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).

Condition or disease Intervention/treatment Phase
Adrenal Insufficiency Drug: Hydrocortisone Drug: Plenadren Phase 4

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Cross over
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Modified-release Compared to Conventional Hydrocortisone on Fatigue, Measured by Ecological Momentary Assessments; a Pilot Study.
Study Start Date : October 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Conventional vs modified hydrocortisone;
5 weeks of conventional hydrocortisone followed by 16 weeks of modified-release hydrocortisone (Plenadren)
Drug: Hydrocortisone
Usual hydrocortisone dosage regimen; 10-40 mg hydrocortisone administered twice or thrice daily for 5 weeks

Drug: Plenadren
10-40 mg modified-release hydrocortisone in tablets, once a day for 16 weeks
Other Name: Modified-release hydrocortisone




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282150


Sponsors and Collaborators
Ulla Feldt-Rasmussen
Investigators
Principal Investigator: Ulla Feldt-Rasmussen, MD, DMSc Rigshospitalet, Denmark

Responsible Party: Ulla Feldt-Rasmussen, Professor, MD, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02282150     History of Changes
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 )
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ulla Feldt-Rasmussen, Rigshospitalet, Denmark:
Fatigue
Quality of Life
Hydrocortisone
Ecological Momentary Assessments

Additional relevant MeSH terms:
Fatigue
Adrenal Insufficiency
Signs and Symptoms
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents