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Safety Study of Entocort for Children With Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT01444092
First received: September 28, 2011
Last updated: September 2, 2016
Last verified: September 2016
Results First Received: May 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Crohn's Disease
Intervention: Drug: Entocort

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
123 patients were screened/enrolled, but only 108 received treatment. The other 15 did not meet the inclusion/exclusion criteria. They only appear in the disposition tables in the CSR (Tables 8 and 10) and did not “start” in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
123 patients were screened/enrolled, but only 108 received treatment. The other 15 did not meet the inclusion/exclusion criteria. They only appear in the disposition tables in the CSR (Tables 8 and 10) and did not “start” in the study.

Reporting Groups
  Description
Entocort Entocort™ EC 9/6/3 mg

Participant Flow:   Overall Study
    Entocort
STARTED   108 
INFORMED CONSENT OBTAINED   108 
COMPLETED   91 
NOT COMPLETED   17 
Adverse Event                8 
Protocol Violation                1 
Withdrawal by Subject                1 
Other Eligibility criteria                7 



  Baseline Characteristics
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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
Entocort Entocort™ EC 9/6/3 mg

Baseline Measures
   Entocort 
Overall Participants Analyzed 
[Units: Participants]
 108 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.7  (2.41) 
Age, Customized 
[Units: Participants]
 
=<8 Yrs   5 
>8 Yrs   103 
Gender 
[Units: Participants]
 
Female   51 
Male   57 
Race/Ethnicity, Customized 
[Units: Participants]
 
Asian   1 
Black Or African American   4 
Other   3 
White   100 


  Outcome Measures
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1.  Primary:   Adverse Event   [ Time Frame: 12 weeks ]

2.  Secondary:   PCDAI   [ Time Frame: Baseline to 8 weeks ]

3.  Secondary:   IMPACT 3   [ Time Frame: Baseline to 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Tore Persson, Study Statistician
Organization: AstraZeneca R&D Molndal
phone: +463177766069 ext: 66069
e-mail: tore.teb.persson@astrazeneca.com



Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT01444092     History of Changes
Other Study ID Numbers: D9422C00001
Study First Received: September 28, 2011
Results First Received: May 19, 2015
Last Updated: September 2, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: The Italian Medicines Agency
Germany: Ministry of Health