Safety Study of Entocort for Children With Crohn's Disease

Padagis

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Entocort

Study type: Interventional

Funder types: Industry

Identifiers

NCT01444092

D9422C00001

Details and patient eligibility

About

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

Full 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

Enrollment: 123 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

Entocort

Experimental group

Description:

Study Medication

Treatment:

Drug: Entocort