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

Status: ot Recruiting

Sex: All

Target Recruitment: 123

Inclusion Criteria

1.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
2.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 within
the last year
3.Subjects with mild to moderate Crohn's disease
4.All subjects must have a stool analysis negative for Clostridium
difficile, Yersinia enterolytica, Campylobacter jejuni, Salmonella,
Shigella, within the 30 days prior to visit 1
5.Alls subjects must have had laboratory assessments within 7 days
prior to visit 1
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects who have had any previous intestinal resection proximal to
and including the ascending colon
2.Subjects with evidence of severe active Crohn's Disease and/or,
structuring and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications
3.Subjects who do not have a negative stool analysis, within the 30 days
prior to Visit 1
4.Subjects who have been screened/or enrolled in this study previously
within the last 6 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to investigate the safety of Entocort (budesonide) in a Paediatric<br>population treated for mild to moderate Crohn's disease;Secondary Objective: To characterize the disease activity in the trial population before and<br>after treatment through the paediatric Crohn's Disease Activity Index<br>(PCDAI); Patient reported outcomes: Quality of Life with Entocort EC<br>treatment based on a subject questionnaire (IMPACT 3);Primary end point(s): Safety measures such as adverse events, GCS-related side effects, HPAaxis measurement, laboratory test results and vital signs will be listed<br>and summarized descriptively, with summaries including all subjects<br>who received at least one dose of study treatment. Summaries will be<br>produced by all patients and by dose group (6 mg or 9 mg).;Timepoint(s) of evaluation of this end point: end of 8 week treatment period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA

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