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 ]

Any kind of adverse event


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