Status:
COMPLETED
Safety Study of Entocort for Children With Crohn's Disease
Lead Sponsor:
Padagis LLC
Conditions:
Crohn's Disease
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease
Detailed 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01444092
Start Date
November 1 2011
End Date
September 1 2014
Last Update
January 6 2022
Active Locations (24)
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1
Research Site
Aurora, Colorado, United States
2
Research Site
Atlanta, Georgia, United States
3
Research Site
Chicago, Illinois, United States
4
Research Site
Oak Lawn, Illinois, United States