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

AstraZeneca AB0 个研究点目标入组 110 人开始时间: 2011年10月20日最近更新: 2015年7月10日

适应症

试验速览

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•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 toxin, 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
•9. All subjects must weigh =15 kg at the time of enrolment.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 110
•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

•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
•16. Subjects taking 6-mercaptopurine or azathioprine should be on stable doses for 3 months prior to study start, and should plan on maintaining this stable dose throughout the course of the study
•17. Subjects taking 5 aminosalicylates should be on stable doses 2 weeks prior to study start and should plan on maintaining this stable dose throughout the course of the study.
•18. Subjects taking Methotrexate should be on stable doses 6 weeks prior to study start and should plan on maintaining this stable dose throughout the course of the study.
•19. Subjects taking antibiotics for Crohn’s disease (e.g., ciprofloxan) should be on stable doses 2 weeks prior to study start.
•21. Subjects taking Enteral Nutrition therapy for Crohn’s disease should be on stable regimen 2 weeks prior to study start and should plan on maintaining this regimen throughout the course of the study.

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