Safety Study of Entocort for Children With Crohn's Disease

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

Detailed Description
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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

Official Title
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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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Entocort


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Entocort<br>Study Medication | Drug: Entocort<br>* Entocort capsules, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Number of patients with at least one adverse event | 12 weeks | 

Secondary Outcome Measures

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