Back to resultsSafety Study of Entocort for Children With Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Entocort
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
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
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Entocort
Arm Description
Study Medication
Outcomes
Primary Outcome Measures
Adverse Event
Number of patients with at least one adverse event
Secondary Outcome Measures
PCDAI
Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).
IMPACT 3
IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01444092
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Padagis LLC
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Entocort
Arm Type
Experimental
Arm Description
Study Medication
Intervention Type
Drug
Intervention Name(s)
Entocort
Intervention Description
Entocort capsules, oral
Primary Outcome Measure Information:
Title
Adverse Event
Description
Number of patients with at least one adverse event
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
PCDAI
Description
Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).
Time Frame
Baseline to 8 weeks
Title
IMPACT 3
Description
IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).
Time Frame
Baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Cohen, MD
Organizational Affiliation
Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA and Emory University School of Medicine, Atlanta, Georgia, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Eklund, MD
Organizational Affiliation
AstraZeneca Pharmaceuticals, Mölndal, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Oak Lawn
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Saint Paul
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Mays Landing
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Morristown
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
München
Country
Germany
Facility Name
Research Site
City
Firenze
Country
Italy
Facility Name
Research Site
City
Messina
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Rzeszów
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wrocław
Country
Poland
Facility Name
Research Site
City
Łódź
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28420280
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=648&filename=D9422C00001_Clinical_Trial_Disclosure_Synopsis.pdf
Description
CSR Synopsis
Learn more about this trial
Safety Study of Entocort for Children With Crohn's Disease
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