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.

DuoCort Pharma AB0 个研究点目标入组 56 人开始时间: 2007年2月22日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-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

•-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).

发起方