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

NCT02282150 | Unknown Phase 4

• 3 other identifiers: PLEN-EMA-hypo2014-002039-32H-1-2014-073
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Adrenal Insufficiency

Keywords

Fatigue; Quality of Life; Hydrocortisone; Ecological Momentary Assessments

Outcome Measures

Primary Outcomes (1)

• Ecological Momentary Assessment (EMA) fatigue profiles

  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 Outcomes (2)

• Quality of Life questionnaires

  At baseline and after 16 weeks of Plenadren (intervention) treatment

• Safety (Biochemical parameters, DEXA scan, 24 hour blood pressure and salivary cortisol)

  At baseline and after 16 weeks of Plenadren (intervention) treatment

Study Arms (1)

Conventional vs modified hydrocortisone;

OTHER

5 weeks of conventional hydrocortisone followed by 16 weeks of modified-release hydrocortisone (Plenadren)

Drug: Hydrocortisone; Drug: Plenadren

Interventions

Hydrocortisone DRUG

Usual hydrocortisone dosage regimen; 10-40 mg hydrocortisone administered twice or thrice daily for 5 weeks

Conventional vs modified hydrocortisone;

Plenadren DRUG

10-40 mg modified-release hydrocortisone in tablets, once a day for 16 weeks

Also known as: Modified-release hydrocortisone

Conventional vs modified hydrocortisone;

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ulla Feldt-Rasmussen: lead

MeSH Terms

Conditions

Adrenal Insufficiency; Fatigue

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Ulla Feldt-Rasmussen, MD, DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, DMSc

Model Details: Cross over

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: November 4, 2014
• Study Start: October 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02