drugset / Trial / NCT00621985

Dexamethasone Treatment of Congenital Adrenal Hyperplasia

NCT00621985 ↗

Phase 2 Completed 5 enrolled Boston Children's Hospital
Non-randomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to determine if dexamethasone given at night is a more effective treatment for congenital adrenal hyperplasia in young children than standard three times per day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more efficient suppression of the hypothalamic-pituitary-adrenal axis. We performed a cross-over trial comparing hormonal control during two 24-hour hospitalizations, one on hydrocortisone and one on nocturnal dexamethasone.

Timeline

Start
2008-04
Primary completion
2009-06
Completion
2009-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Dexamethasone Admission vs Hydrocortisone Admission; p = 0.09; Percent Difference -19; t-test, 2 sided NCT00621985 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule — —
Subject Hydrocortisone Other / unclassified — —