Phase 2
Completed N=5
Dexamethasone Treatment of Congenital Adrenal Hyperplasia
Adrenal Hyperplasia, Congenital
Source: ClinicalTrials.gov NCT00621985 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcomePrimary: Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens — 3.16; 3.91 Log Mean Area Under the Curve — p=0.09
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens |
3.16; 3.91 | 0.09 |
Eligibility Criteria
Inclusion Criteria
- Classic salt-wasting 21-hydroxylase deficient congenital adrenal hyperplasia
- Pre-pubertal children with bone ages below 8 years
Exclusion Criteria
- Age less than 2 years
- Patients with additional medical conditions necessitating glucocorticoid therapy.
- Patients on phenytoin, barbiturates, and rifampin as these medications accelerate the metabolism of glucocorticoids.
- Patients on ketoconazole as this medication increases the bioavailability of glucocorticoids.
Data sourced from ClinicalTrials.gov (NCT00621985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.