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Keep this study
Lead
Padagis LLC
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
Age
5–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety Study of Entocort for Children With Crohn's Disease
