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Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia

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ClinicalTrials.gov Identifier: NCT00519818
Recruitment Status : Completed
First Posted : August 23, 2007
Results First Posted : August 27, 2014
Last Update Posted : March 24, 2016
Sponsor:
Collaborator:
National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
Diurnal Limited

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Congenital Adrenal Hyperplasia
21-Hydroxylase Deficiency
Adrenogenital Syndrome
Interventions Drug: Chronocort
Drug: Cortef
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cortef Then Chronocort
Hide Arm/Group Description Hydrocortisone immediate release tablet treatment then Modified release hydrocortisone
Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title Cortef Then Chronocort
Hide Arm/Group Description Hydrocortisone immediate release 3 times daily total dose 30mg for 7 days, then hydrocortisone modified release tablet 30mg once nightly for 28days
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
26.8  (3.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
7
  50.0%
Male
7
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose).
Hide Description [Not Specified]
Time Frame Cortef after one week, Chronocort after one month
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Cortef Chronocort
Hide Arm/Group Description:
Hydrocortisone immediate release tablet
Hydrocortisone modified release tablet treatment
Overall Number of Participants Analyzed 14 14
Mean (Standard Error)
Unit of Measure: h*nmol/l
5380  (414) 3973  (166)
2.Secondary Outcome
Title 17 Hydroxyprogesterone at 08.00 Hours
Hide Description [Not Specified]
Time Frame Cortef after one week compared with Chronocort after one month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cortef Chronocort
Hide Arm/Group Description:
Hydrocortisone immediate release tablet
Hydrocortisone modified release tablet treatment
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: nmol/l
16.4  (27.9) 86.9  (181.7)
Time Frame Adverse events for each subject were followed for 1 week in Cortef, 4 weeks on Chronocort and 4 weeks follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chronocort Cortef
Hide Arm/Group Description Hydrocortisone modified release tablet Hydrocortisone immediate release tablet
All-Cause Mortality
Chronocort Cortef
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chronocort Cortef
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chronocort Cortef
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/14 (28.57%)      3/14 (21.43%)    
Nervous system disorders     
Headache   4/14 (28.57%)  4 3/14 (21.43%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard JM Ross
Organization: Diurnal Ltd
Phone: 0044 114 2712386
EMail: r.j.ross@sheffield.ac.uk
Layout table for additonal information
Responsible Party: Diurnal Limited
ClinicalTrials.gov Identifier: NCT00519818     History of Changes
Other Study ID Numbers: 070211
First Submitted: August 22, 2007
First Posted: August 23, 2007
Results First Submitted: June 28, 2011
Results First Posted: August 27, 2014
Last Update Posted: March 24, 2016