Safety Study of Entocort for Children With Crohn's Disease

Phase 3

Completed

Brief Summary: A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease

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

Recruitment & Eligibility

Inclusion Criteria

All male and female subjects must be aged 5 to 17, inclusive, and must not have reached their 18th birthday by the estimated final office visit.
Subject must be diagnosed with active Crohn's disease of the ileum and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal erosions and/or histology.
Subjects with mild to moderate Crohn's disease.
All subjects must have a stool analysis negative for Clostridium difficile toxin, Yersinia enterolytica, Campylobacter jejuni, Salmonella, Shigella, within the 30 days prior to visit 1.
All subjects must have had laboratory assessments within 7 days prior to visit 1.
All subjects must weigh >= 15 kg at time of enrollment

Exclusion Criteria

Subjects who have had any previous intestinal resection proximal to and including the ascending colon
Subjects with evidence of severe active Crohn's disease and/or, stricturing and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications
Subjects who do not have a negative stool analysis, within the 30 days prior to visit 1
Subjects who have been screened/or enrolled in this study previously within the last 30 days
Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender

Arm && Interventions

Group	Intervention	Description
Entocort	Entocort	Study Medication

Primary Outcome Measures

Name	Time	Method
Adverse Event	12 weeks	Number of patients with at least one adverse event

Secondary Outcome Measures

Name	Time	Method
PCDAI	Baseline to 8 weeks	Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).
IMPACT 3	Baseline to 8 weeks	IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).