Clinical trial NCT01444092: Safety Study of Entocort for Children With Crohn's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 123
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Adverse Event
timeFrame: 12 weeks
Secondary outcomes:
measure: PCDAI
timeFrame: Baseline to 8 weeks
measure: IMPACT 3
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Oak Lawn
country: United States
facility: Research Site
state: Illinois
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Saint Paul
country: United States
facility: Research Site
state: Minnesota
city: Mays Landing
country: United States
facility: Research Site
state: New Jersey
city: Morristown
country: United States
facility: Research Site
state: New Jersey
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: London
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: München
country: Germany
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
Study officials:
affiliation: Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA and Emory University School of Medicine, Atlanta, Georgia, USA
name: Stanley Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Pharmaceuticals, Mölndal, Sweden
name: Stefan Eklund, MD
role: STUDY_DIRECTOR
References:
citation: Cohen SA, Aloi M, Arumugam R, Baker R, Bax K, Kierkus J, Koletzko S, Lionetti P, Persson T, Eklund S. Enteric-coated budesonide for the induction and maintenance of remission of Crohn's disease in children. Curr Med Res Opin. 2017 Jul;33(7):1261-1268. doi: 10.1080/03007995.2017.1313213. Epub 2017 Apr 19.