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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®
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infacort
Hide Arm/Group Description

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

Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Infacort
Hide Arm/Group Description

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

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
24
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 24 participants
718.1
(16 to 1708)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
11
  45.8%
Male
13
  54.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
24
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 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  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 24 participants
24
1.Primary Outcome
Title Serum Cortisol Concentration up to 240 Minutes
Hide Description The primary endpoint will be the maximum levels of serum cortisol concentration up to 240 minutes after intake of study drug as determined by the central laboratory.
Time Frame 240 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infacort
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
575.8
(47.9%)
2.Secondary Outcome
Title Serum Cortisol Concentration up to 6 Hours
Hide Description Serum cortisol concentration 240 minutes after intake of study drug as determined by the central laboratory
Time Frame 240 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infacort
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
60.1
(131.7%)
3.Secondary Outcome
Title Subject Assessment of Taste of the Product
Hide Description

Palatability of the investigational product as determined by parent/carer responses to the following questions:

Question 1: My child found swallowing easy. Question 2: My child showed a positive reaction after Infacort was given. Question 3: I would be happy to give my child Infacort in the future. Question 4: Overall, I would prefer Infacort for my child over the usual hydrocortisone medication.

Time Frame 1 minute
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Question 1 Question 2 Question 3 Question 4
Hide Arm/Group Description:
Percentage of parents/carers that agreed, or strongly agreed with the statement: My child found swallowing easy.
Percentage of parents/carers that agreed, or strongly agreed with the statement: My child showed a positive reaction after Infacort was given.
Percentage of parents/carers that agreed, or strongly agreed with the statement: I would be happy to give my child Infacort in the future.
Percentage of parents/carers that agreed, or strongly agreed with the statement: Overall, I would prefer Infacort for my child over the usual hydrocortisone medication.
Overall Number of Participants Analyzed 23 23 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
19
  82.6%
15
  65.2%
21
  95.5%
21
  95.5%
4.Secondary Outcome
Title Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE)
Hide Description

SAEs and AEs reported over the study period.

N.B., Data will not be entered in this section as this is described within the Adverse Events section.

Time Frame 7-10 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events will be recorded from the time of first intake of Infacort® until Visit 4. Serious Adverse Events (SAEs) will be recorded from the time of first intake of Infacort® until 7 days following administration of Infacort®. Any SAEs experienced after this 7-day period will be reported to the sponsor if the investigator suspects a causal relationship to the study drug.
 
Arm/Group Title Infacort
Hide Arm/Group Description

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

All-Cause Mortality
Infacort
Affected / at Risk (%)
Total   0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Infacort
Affected / at Risk (%) # Events
Total   0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Infacort
Affected / at Risk (%) # Events
Total   8/24 (33.33%)    
Gastrointestinal disorders   
Diarrhoea * 1  3/24 (12.50%)  3
Vomiting * 1  2/24 (8.33%)  2
Infantile spitting up * 1  1/24 (4.17%)  2
General disorders   
Fatigue * 1  1/24 (4.17%)  1
Skin and subcutaneous tissue disorders   
Rash * 1  2/24 (8.33%)  2
Hyperhidrosis * 1  1/24 (4.17%)  2
1
Term from vocabulary, MedDRA v18.1
*
Indicates events were collected by non-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
Name/Title: Dr John Porter
Organization: Diurnal Limited
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