Text Size
Trial record 6 of 46 for:    "Adrenal Hyperplasia, Congenital" [DISEASE]
Previous Study | Return to List | Next Study

Dexamethasone Treatment of Congenital Adrenal Hyperplasia

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00621985
First received: February 11, 2008
Last updated: January 26, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Adrenal Hyperplasia, Congenital
 Drug: dexamethasone
Drug: Hydrocortisone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dexamethasone Treatment of Congenital Adrenal Hyperplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens [ Time Frame: 23 hours ] [ Designated as safety issue: No ]
    Each subject was admitted for 2 24 hour hospitalizations, one on hydrocortisone and one on dexamethasone. Due to the timing of blood draws, the serum hormonal profile was only measured for 23 hours. The primary outcome was the Percent Difference in the Mean log transformed Area under the curve of 17-hydroxyprogesterone between the two regimens.


Enrollment: 5
Study Start Date: April 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Experimental therapy with nocturnal dexamethasone.
 Drug: dexamethasone
Dexamethasone will be given at a dose that equals 1/50 of the total daily hydrocortisone dose of the patient. It will be given in solution form at 10 PM for 3 days.
Other Name: Decadron
Drug: Hydrocortisone
Subjects were given their baseline hydrocortisone regimen which was three times daily for 4 of the subjects and twice daily for one subject. Doses were given at 8 AM, 2 PM, and 8 PM. The 2 PM time point was skipped for the subject who received hydrocortisone twice daily. Doses ranged from 6.9 to 18.5 milligrams per meter squared per day and were based on each individual's baseline regimen.

Detailed Description:

This is a Phase II clinical trial, intended to estimate the effect of instituting Dexamethasone therapy in comparison to prior standard therapy. Each subject provides his own baseline data. There is no control group. Patients with CAH who meet inclusion criteria will be admitted to the clinical research center for two 24 hour hospitalizations. Adrenal hormone profiles will be measured during each hospitalization. The patient will take his or her baseline hydrocortisone regimen during one hospitalization and a new regimen consisting of a single daily nocturnal dose of Dexamethasone during the second hospitalization.

  Eligibility

Ages Eligible for Study:   2 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621985

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Joseph Majzoub, MD Children's Hospital Boston
  More Information

Publications:

Responsible Party: Joseph Majzoub, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00621985     History of Changes
Other Study ID Numbers: 08-01-0025
Study First Received: February 11, 2008
Results First Received: September 17, 2010
Last Updated: January 26, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Hyperplasia
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Pathologic Processes
 Dexamethasone acetate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Dexamethasone
Hydrocortisone
Dexamethasone 21-phosphate
BB 1101
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013