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Dexamethasone Treatment of Congenital Adrenal Hyperplasia

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ClinicalTrials.gov Identifier: NCT00621985
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
Boston Children’s Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adrenal Hyperplasia, Congenital
Interventions Drug: dexamethasone
Drug: Hydrocortisone
Enrollment 5
Recruitment Details Subjects were recruited from the Endocrine Clinic at Children's Hospital Boston from April through November 2008.
Pre-assignment Details This was a cross over study. All subjects were admitted on their baseline hydrocortisone regimen for a 24 hour hospital admission. They then had a second hospital admission within 8 weeks while being administered the dexamethasone therapy.
Arm/Group Title Experimental
Hide Arm/Group Description Baseline hydrocortisone was given at a dose determined by the subject's primary endocrinologist and was given either 2 or 3 times per day as per their home regimen. Experimental therapy with nocturnal dexamethasone given at a dose equivalent to 1/50th of the total daily hydrocortisone dose. This dose was given at 10 PM for three nights with the admission to the hospital occurring on the 3rd day prior to the 3rd evening dose.
Period Title: Hydrocortisone Admission
Started 5
Completed 5
Not Completed 0
Period Title: Dexamethasone Admission
Started 5
Completed 4
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Experimental Group
Hide Arm/Group Description These subjects were admitted twice, once while on baseline hydrocortisone and once on dexamethasone.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
5
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens
Hide Description 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.
Time Frame 23 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Only four participants completed both the hydrocortisone and dexamethasone admissions.
Arm/Group Title Dexamethasone Admission Hydrocortisone Admission
Hide Arm/Group Description:
This is the second admission of the protocol during which the subject received dexamethasone.
This is the first admission of the protocol during which the subject received hydrocortisone.
Overall Number of Participants Analyzed 4 4
Log Mean (Standard Deviation)
Unit of Measure: Log Mean Area Under the Curve
3.16  (0.93) 3.91  (0.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexamethasone Admission, Hydrocortisone Admission
Comments

A t-test was performed comparing the mean long transformed area under the curve of 17-hydroxyprogesterone between the dexamethasone and hydrocortisone arms. The percent difference in mean log AUC was calculated as:

(Mean log AUC on dexamethasone - Mean log AUC on hydrocortisone)/Mean log AUC on hydrocortisone

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Difference
Estimated Value -19
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexamethasone Admission Hydrocortisone Admission
Hide Arm/Group Description This is the second admission of the protocol during which the subject received dexamethasone. This is the first admission of the protocol during which the subject received hydrocortisone.
All-Cause Mortality
Dexamethasone Admission Hydrocortisone Admission
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dexamethasone Admission Hydrocortisone Admission
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dexamethasone Admission Hydrocortisone Admission
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/5 (0.00%)    
Injury, poisoning and procedural complications     
IV infiltration * [1]  1/5 (20.00%)  1 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
IV accidentally placed intrarterially and had to be removed. Study was discontinued for this individual. There was no permanent injury or adverse sequelae.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joseph Majzoub
Organization: Children's Hospital Boston
Phone: 617-355-7476
Responsible Party: Joseph Majzoub, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00621985     History of Changes
Other Study ID Numbers: 08-01-0025
First Submitted: February 11, 2008
First Posted: February 22, 2008
Results First Submitted: September 17, 2010
Results First Posted: February 23, 2011
Last Update Posted: February 23, 2011