Randomised, placebo-controlled, double-blinded, four-way crossover trial to demonstrate the comparative pharmacodynamic equivalence of a non-invasive diagnostic test for adrenal insufficiency in a healthy population: the STARLIT-2 study protocol

Kathryn L Date,Kathleen Baster,Sharon L Caunt,Judith Cohen,Miguel Debono,Jane Fearnside,Trevor N Johnson,Richard J Ross,Rosie N Taylor,Charlotte J Elder

doi:10.1136/bmjopen-2024-094830

Randomised, placebo-controlled, double-blinded, four-way crossover trial to demonstrate the comparative pharmacodynamic equivalence of a non-invasive diagnostic test for adrenal insufficiency in a healthy population: the STARLIT-2 study protocol

Kathryn L Date, Kathleen Baster + Show 8 more

https://doi.org/10.1136/bmjopen-2024-094830

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Journal: BMJ Open

Publication Date: Dec 22, 2024

#Short Synacthen Test #South Central Hampshire #Serum Cortisol #Research Ethics Committee #Drug Administration #Cost-effective Test #Adrenal Insufficiency #Study Visits #Primary Outcome Measures #Cent Agreement

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IntroductionCortisol is an essential stress hormone and failure of its production, known as adrenal insufficiency (AI), is associated with significant mortality due to adrenal crisis. The Short Synacthen Test (SST)...

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Randomised, placebo-controlled, double-blinded, four-way crossover trial to demonstrate the comparative pharmacodynamic equivalence of a non-invasive diagnostic test for adrenal insufficiency in a healthy population: the STARLIT-2 study protocol