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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 : Unknown
Verified February 2017 by Ulla Feldt-Rasmussen, Rigshospitalet, Denmark.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE October 26, 2014
First Posted Date  ICMJE November 4, 2014
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism
Official Title  ICMJE Effect of Modified-release Compared to Conventional Hydrocortisone on Fatigue, Measured by Ecological Momentary Assessments; a Pilot Study.
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Cross over
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adrenal Insufficiency
Intervention  ICMJE
  • 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
Study Arms  ICMJE Conventional vs modified hydrocortisone;
5 weeks of conventional hydrocortisone followed by 16 weeks of modified-release hydrocortisone (Plenadren)
Interventions:
  • Drug: Hydrocortisone
  • Drug: Plenadren
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 3, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02282150
Other Study ID Numbers  ICMJE PLEN-EMA-hypo
2014-002039-32 ( EudraCT Number )
H-1-2014-073 ( Other Identifier: Health Research Ethics in Capital Region of Denmark )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ulla Feldt-Rasmussen, Rigshospitalet, Denmark
Study Sponsor  ICMJE Ulla Feldt-Rasmussen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulla Feldt-Rasmussen, MD, DMSc Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP