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Safety Study of Entocort for Children With Crohn's Disease

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ClinicalTrials.gov Identifier: NCT01444092
Recruitment Status : Completed
First Posted : September 30, 2011
Results First Posted : August 11, 2016
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Perrigo Company

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Crohn's Disease
Intervention: Drug: Entocort

  Participant Flow

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

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]
Count of Participants 		 
Female      51  47.2% 
Male      57  52.8% 
Race/Ethnicity, Customized 
[Units: Participants]
 		 
Asian   1 
Black Or African American   4 
Other   3 
White   100 


  Outcome Measures

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

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

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


  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: Beatriz North
Organization: Perrigo
phone: 718-960-0163
e-mail: beatriz.north@perrigo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT01444092     History of Changes
Other Study ID Numbers: D9422C00001
First Submitted: September 28, 2011
First Posted: September 30, 2011
Results First Submitted: May 19, 2015
Results First Posted: August 11, 2016
Last Update Posted: January 4, 2017