Status:
COMPLETED
Safety and Maintenance 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 for Maintenance of 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 as a Maintenance Treatment for 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.
- All subjects must weight \>= 15 kg at the time of enrollment.
- Subjects must have been diagnosed and treated for 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 and have a PCDAI \<= 10
Exclusion
- Subjects who have had any previous intestinal resection proximal to and including the ascending colon.
- Subjects with evidence of active Crohn's disease (PCDAI \> 10) and/or stricturing, prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications.
- Subjects with morning cortisol level \<150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender (NOTE: Subjects from the induction protocol with abnormal morning cortisol/DHEA-S levels at Visit 4, who otherwise meet the eligibility criteria, may be enrolled if the investigator decides that Entocort 6 mg is an appropriate therapy option.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01453946
Start Date
December 1 2011
End Date
February 1 2014
Last Update
January 6 2022
Active Locations (19)
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1
Research Site
Atlanta, Georgia, United States
2
Research Site
Oak Lawn, Illinois, United States
3
Research Site
Newton, Massachusetts, United States
4
Research Site
Saint Paul, Minnesota, United States