Safety Study of Entocort for Children With Crohn's Disease

Completed · Phase 3

Conditions studied: Crohn's Disease

In brief

A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease

Key facts

Study ID

NCT01444092

Run by

Padagis LLC

People needed

123

Starts

2011-11-01

Expected to finish

2014-09-01

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.
• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Aurora, Colorado, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Oak Lawn, Illinois, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Saint Paul, Minnesota, United States
• Research Site — Mays Landing, New Jersey, United States
• Research Site — Morristown, New Jersey, United States
• Research Site — Buffalo, New York, United States
• Research Site — Greenville, North Carolina, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Halifax, Nova Scotia, Canada
• Research Site — London, Ontario, Canada
• Research Site — Toronto, Ontario, Canada
• Research Site — München, Germany
• Research Site — Florence, Italy
• Research Site — Messina, Italy
• Research Site — Naples, 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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