Clinical Trial: Safety and Maintenance Study of Entocort for Children With Crohn's Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Y
Brief Summary: A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.
Detailed Summary: 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
Sponsor: Perrigo Company
Current Primary Outcome: Adverse Event [ Time Frame: 16 weeks ]
Original Primary Outcome: Adverse Events [ Time Frame: 12 Weeks ]
Current Secondary Outcome:
- PCDAI [ Time Frame: 12 weeks ]Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)
- IMPACT 3 [ Time Frame: 12 weeks ]IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE
Original Secondary Outcome:
- IMPACT 3 Questionnaire for children with Inflammatory Bowel Disease [ Time Frame: 8 Weeks ]
- Disease activity on trial population before and after treatment through Paediatric Crohn's Disease Activity Index (PCDAI) [ Time Frame: Baseline and 8 weeks ]
Information By: Perrigo Company
Dates:
Date Received: October 14, 2011
Date Started: December 2011
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016