Safety and Maintenance Study of Entocort for Children With Crohn's Disease

Completed · Phase 3

Conditions studied: Crohn's Disease

In brief

A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.

Key facts

Study ID

NCT01453946

Run by

Padagis LLC

People needed

55

Starts

2011-12-01

Expected to finish

2014-02-01

Last updated by the study team

2022-01-06

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Atlanta, Georgia, United States
• Research Site — Oak Lawn, Illinois, United States
• Research Site — Newton, Massachusetts, United States
• Research Site — Saint Paul, Minnesota, United States
• Research Site — Mays Landing, New Jersey, United States
• Research Site — Buffalo, New York, United States
• Research Site — Houston, Texas, United States
• Research Site — Halifax, Nova Scotia, Canada
• Research Site — London, Ontario, Canada
• Research Site — München, Germany
• Research Site — Nuremberg, Germany
• Research Site — Florence, Italy
• Research Site — Messina, Italy
• Research Site — Roma, Italy
• Research Site — Krakow, Poland
• Research Site — Lodz, Poland
• Research Site — Rzeszów, Poland
• Research Site — Warsaw, Poland
• Research Site — Wroclaw, Poland

Full record on ClinicalTrials.gov

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