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: November 16, 2016

Last verified: November 2016

History of Changes

Results First Received: May 19, 2015

Study Type:	Interventional
Study Design:	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.
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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

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1. Primary:

Adverse Event [ Time Frame: 12 weeks ]

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2. Secondary:

PCDAI [ Time Frame: Baseline to 8 weeks ]

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3. Secondary:

IMPACT 3 [ Time Frame: Baseline to 8 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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
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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: Beatriz North
Organization: Perrigo
phone: 718-960-0163
e-mail: beatriz.north@perrigo.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:	November 16, 2016

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