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Safety and Maintenance 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
Padagis LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.
  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Entocort

Arm Description

Study Medication

Outcomes

Primary Outcome Measures

Adverse Event
Any kind of adverse event

Secondary Outcome Measures

PCDAI
Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)
IMPACT 3
IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE

Full Information

First Posted
October 14, 2011
Last Updated
January 4, 2022
Sponsor
Padagis LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01453946
Brief Title
Safety and Maintenance 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 as a Maintenance Treatment for 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
December 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 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 for Maintenance of 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 as a Maintenance Treatment for 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
Keywords
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
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Entocort
Arm Type
Other
Arm Description
Study Medication
Intervention Type
Drug
Intervention Name(s)
Entocort
Intervention Description
Entocort capsules, taken orally, 6 mg daily.
Primary Outcome Measure Information:
Title
Adverse Event
Description
Any kind of adverse event
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
PCDAI
Description
Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)
Time Frame
12 weeks
Title
IMPACT 3
Description
IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE
Time Frame
12 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. 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 Exclusion Criteria: 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.
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
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
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Oak Lawn
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Newton
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
Buffalo
State/Province
New York
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
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
München
Country
Germany
Facility Name
Research Site
City
Nürnberg
Country
Germany
Facility Name
Research Site
City
Firenze
Country
Italy
Facility Name
Research Site
City
Messina
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=649&filename=ADMIRe_D9422C00002_CTD_Synopsis.pdf
Description
CSR Synopsis

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

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