A randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency.

• Conditions: Primary adrenal insufficiency; MedDRA version: 9.1Level: LLTClassification code 10052381Term: Primary adrenal insufficiency

• Registration Number: EUCTR2006-007084-89-SE
• Lead Sponsor: DuoCort Pharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

-Males and females; age 18 years and above
-Previously diagnosed (e.g. more than 6 months ago) primary adrenal insufficiency with a stable daily glucocorticoid substitution dose of at least 3 months prior to study entry.
-An oral hydrocortisone substation therapy dose of 30 mg total daily dose
-Signed informed consent to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepaticobiliary, pancreatic disease, which in the investigators judgment may interfere with the study assessment or completion of the study
-Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L.
-Clinical or laboratory signs of significant GI emptying or motility disease or disorder including pharmacological therapies affecting GI emptying or motility, which in the investigators judgment may interfere with the ADME of hydrocortisone
-Any medication with agents which may interfere with hydrocortisone kinetics within 14 days prior to study start
-Any additional underlying disease that may need regular or periodic pharmacological treatment with glucocorticoids.
-Administration of other investigational drugs within eight weeks preceding the pre-entry examination
-Alcohol/drug abuse or any condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator
-Pregnant or lactating women
-Regular DHEA medication for the past 4 weeks.
-Oral oestrogen medication for the past 4 weeks (transdermal oestrogen medication is allowed)
-Deranged mineralcorticoid status as determined by clinical (hypotension, ortostatic hypotension) and biochemical status (PRA outside the normal range and abnormal serum sodium and potassium levels).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare bioavailability between a once-daily modified-release hydrocortisone tablet and a conventional thrice-daily replacement therapy in patients with chronic primary adrenal insufficiency.;Secondary Objective: To compare safety, tolerability and efficacy of the novel modified release formulation to the conventional thrice-daily replacement therapy.<br><br>To assess the safety of using the novel modified release formulation as rescue therapy during minor intercurrent illnesses in patients with primary adrenal insufficiency.<br><br>To assess long-term safety, tolerability and efficacy of the novel modified release formulation during glucocorticoid replacement therapy. <br>;Primary end point(s): To evaluate the safety and efficacy of dosing the novel combined modified release formulation in comparison to conventional therapy as assessing bioavailability and pharmacokinetics by difference in total S-cortisol AUC0-24h of od compared to tid therapy for all subjects (study arm I+II)