Safety and Maintenance study of Entocort for Children with Crohn's Disease

Study identifier:D9422C00002

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Medical condition

Crohn's disease

Phase

Phase 3

Healthy volunteers

No

Study drug

Entocort

Sex

All

Actual Enrollment

55

Study type

Interventional

Age

5 Years - 17 Years

Date

Study Start Date: 01 Dec 2011
Primary Completion Date: 01 Feb 2014
Study Completion Date: 01 Feb 2014

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2015 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria