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Treatment of Adrenal Insufficiency in Children

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ClinicalTrials.gov Identifier: NCT02720952
Recruitment Status : Completed
First Posted : March 28, 2016
Results First Posted : April 11, 2017
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
TAIN (Treatment of Adrenal Insufficiency in Neonates) consortium
Information provided by (Responsible Party):
Diurnal Limited

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Adrenal Insufficiency
Intervention: Drug: Infacort®

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Infacort

Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).

The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.

Infacort®: dry granule formulation of hydrocortisone


Participant Flow:   Overall Study
    Infacort
STARTED   24 
COMPLETED   24 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Infacort

Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).

The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.

Infacort®: dry granule formulation of hydrocortisone


Baseline Measures
   Infacort 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      24 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Days]
Mean (Full Range)
 718.1 
 (16 to 1708) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  45.8% 
Male      13  54.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      24 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      24 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
Germany   24 


  Outcome Measures

1.  Primary:   Serum Cortisol Concentration up to 240 Minutes   [ Time Frame: 240 minutes ]

2.  Secondary:   Serum Cortisol Concentration up to 6 Hours   [ Time Frame: 240 minutes ]

3.  Secondary:   Subject Assessment of Taste of the Product   [ Time Frame: 1 minute ]

4.  Secondary:   Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE)   [ Time Frame: 7-10 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Dr John Porter
Organization: Diurnal Limited
e-mail: info@diurnal.co.uk



Responsible Party: Diurnal Limited
ClinicalTrials.gov Identifier: NCT02720952     History of Changes
Other Study ID Numbers: Infacort-003
First Submitted: March 16, 2016
First Posted: March 28, 2016
Results First Submitted: February 28, 2017
Results First Posted: April 11, 2017
Last Update Posted: May 19, 2017