Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519818
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2007-08-22
Brief Title:
Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia
Sponsor:
Diurnal Limited
Organization:
Diurnal Limited
Study Overview
Official Title:
A Phase 2 Open Label Crossover Pharmacokinetic and Pharmacodynamic Study to Compare Chronocort Versus Cortef in Patients With CAH
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test a new extended release form of hydrocortisone called Chronocort in patients with congenital adrenal hyperplasia CAH People with CAH do not make enough of the adrenal hormones cortisol and aldosterone and their adrenal glands make too much of the sex hormone androgen Medicines called glucocorticoids hydrocortisone dexamethasone and prednisone are currently used to treat CAH but finding the best dose of these drugs that effectively lowers androgens without causing undesirable side effects such as weight gain and slow growth rate in children is often difficult to achieve
Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this study Children 16 years of age and older are eligible with confirmation by bone age that they are no longer growing
Participants undergo the following tests and procedures during two inpatient visits one month apart at the NIH Clinical Center
Medical history and physical examination
Medications Following 7 days of Cortef standard drug treatment for CAH patients begin taking Chronocort on day 3 of hospitalization and continue the tablets once a day for 1 month
Blood tests A catheter plastic tube is inserted in a vein and left in place for frequent blood draws in order to avoid repeated needlesticks Blood is drawn for chemistries blood count pregnancy test in women and for serial tests up to 26 samples in a 24-hour period to measure hormone levels
24-hour urine test
Height and weight measurements
Between the two hospitalizations patients are contacted by NIH weekly to check for possible side effects from Chronocort Two weeks after the first visit patients also will have blood drawn by their regular doctor or a local clinic A few days before the second hospitalization patients undergo a 20-minute telephone questionnaire about energy level and well being
About 30 days after discharge from the second hospitalization patients are followed up with a telephone call to see how they are doing
Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this study Children 16 years of age and older are eligible with confirmation by bone age that they are no longer growing
Participants undergo the following tests and procedures during two inpatient visits one month apart at the NIH Clinical Center
Medical history and physical examination
Medications Following 7 days of Cortef standard drug treatment for CAH patients begin taking Chronocort on day 3 of hospitalization and continue the tablets once a day for 1 month
Blood tests A catheter plastic tube is inserted in a vein and left in place for frequent blood draws in order to avoid repeated needlesticks Blood is drawn for chemistries blood count pregnancy test in women and for serial tests up to 26 samples in a 24-hour period to measure hormone levels
24-hour urine test
Height and weight measurements
Between the two hospitalizations patients are contacted by NIH weekly to check for possible side effects from Chronocort Two weeks after the first visit patients also will have blood drawn by their regular doctor or a local clinic A few days before the second hospitalization patients undergo a 20-minute telephone questionnaire about energy level and well being
About 30 days after discharge from the second hospitalization patients are followed up with a telephone call to see how they are doing
Detailed Description:
Congenital adrenal hyperplasia CAH due to 21-hydroxylase deficiency is a disease of the adrenal cortex characterized by cortisol deficiency with or without aldosterone deficiency and androgen excess The severe or classic form occurs in 1 in 15000 births worldwide while the mild non-classic form is a common cause of hyperandrogenism The discovery of glucocorticoid therapy as a treatment for CAH occurred in the 1950s resulting in patients with classic CAH surviving to live a normal lifespan However existing treatment is suboptimal and many unresolved clinical problems exist Standard hormone replacement often fails to normalize the growth and development of children with CAH and adults may experience iatrogenic Cushing syndrome hyperandrogenism infertility or the development of the metabolic syndrome Chronocort a newly-developed formulation of hydrocortisone results in a slow release of hydrocortisone that is designed to mimic the normal cortisol circadian rhythm This new medical strategy physiologic cortisol replacement offers the prospect of an improved outcome of treatment Chronocort has been safely given to healthy adult males in pharmacokinetic studies This first ever study in patients with CAH is a pharmacokineticpharmacodynamic study comparing Chronocort to Cortef the conventional immediate-release form of hydrocortisone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None