Safety Study of Entocort for Children With Crohn's Disease

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Perrigo Company
• Treatments: Budesonide

Criteria

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