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Completed
NCT05222152
Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency
Conditions: Primary Adrenal Insufficiency
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 58
Sponsor: Neurocrine UK Limited
Location: Diurnal Investigational Site in Hamburg Hamburg
Summary
This study is a double-blind, double-dummy, two-way cross-over, randomised, Phase II study to be conducted at approximately 6 investigational sites in 2 countries. The study will compare the efficacy, safety and tolerability of twice daily Chronocort, a modified-release hydrocortisone, with once daily Plenadren, a modified-release hydrocortisone, over a treatment period of up to 2 months in participants aged 18 years and over, diagnosed with primary Adrenal Insufficiency (AI).
Eligibility Criteria
Inclusion Criteria:
* Male or female participants must be aged 18 years or older at the time of signing the informed consent.
* Participants with known (documented) primary AI, defined as early morning pre-dose cortisol \
Source: ClinicalTrials.gov (NCT05222152). StuddyBuddy aggregates publicly available trial information.
