Safety Study of Entocort for Children With Crohn's Disease
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
1 other identifier
interventional
123
5 countries
24
Brief Summary
A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2011
Typical duration for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
September 30, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
August 11, 2016
CompletedJanuary 6, 2022
January 1, 2022
2.8 years
September 28, 2011
May 19, 2015
January 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Event
Number of patients with at least one adverse event
12 weeks
Secondary Outcomes (2)
PCDAI
Baseline to 8 weeks
IMPACT 3
Baseline to 8 weeks
Study Arms (1)
Entocort
EXPERIMENTALStudy Medication
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Padagis LLClead
Study Sites (24)
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
Napoli, 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
Related Publications (1)
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.
PMID: 28420280DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Beatriz North
- Organization
- Perrigo
Study Officials
- PRINCIPAL INVESTIGATOR
Stanley Cohen, MD
Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA and Emory University School of Medicine, Atlanta, Georgia, USA
- STUDY DIRECTOR
Stefan Eklund, MD
AstraZeneca Pharmaceuticals, Mölndal, Sweden
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2011
First Posted
September 30, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
January 6, 2022
Results First Posted
August 11, 2016
Record last verified: 2022-01