Status:
COMPLETED
Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency
Lead Sponsor:
Shire
Conditions:
Adrenal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is 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 hy...
Detailed Description
Adrenal insufficiency is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data...
Eligibility Criteria
Inclusion
- Previously diagnosed (e.g. more than 6 months ago) primary adrenal insufficiency with a stable daily glucocorticoid substitution dose for at least 3 months prior to study entry
- Signed informed consent to participate in the study.
Exclusion
- Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, Hepatobiliary, pancreatic disease
- Clinically significant renal dysfunction
- Clinical or laboratory signs of significant gastrointestinal emptying or motility disease
- Any medication with agents which could interfere with hydrocortisone kinetics
- Pregnant or lactating women
- Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
- Oral oestrogen medication for the past 4 weeks
- Deranged mineralocorticoid status
Key Trial Info
Start Date :
August 21 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00915343
Start Date
August 21 2007
End Date
January 28 2009
Last Update
November 24 2020
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