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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 27 January 2014
Main ID:  EUCTR2011-003743-22-IT
Date of registration: 08/03/2012
Prospective Registration: No
Primary sponsor: ASTRAZENECA
Public 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
Scientific 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
Date of first enrolment: 01/12/2011
Target sample size: 110
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003743-22
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1  
Phase: 
Countries of recruitment
Canada Germany Italy United States
Contacts
Name: AstraZeneca Clinical Study Informat   
Address:  AstraZeneca Clinical Study Information 00000 AstraZeneca Clinical Study Information United States
Telephone: 001 800 236-9933
Email: information.center@astrazeneca.com
Affiliation:  AstraZeneca Clinical Study Information
Name: AstraZeneca Clinical Study Informat   
Address:  AstraZeneca Clinical Study Information 00000 AstraZeneca Clinical Study Information United States
Telephone: 001 800 236-9933
Email: information.center@astrazeneca.com
Affiliation:  AstraZeneca Clinical Study Information
Key inclusion & exclusion criteria
Inclusion criteria:
1.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
2.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 within
the last year
3.Subjects with mild to moderate Crohn's disease
4.All subjects must have a stool analysis negative for Clostridium
difficile, Yersinia enterolytica, Campylobacter jejuni, Salmonella,
Shigella, within the 30 days prior to visit 1
5.Alls subjects must have had laboratory assessments within 7 days
prior to visit 1
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Subjects who have had any previous intestinal resection proximal to
and including the ascending colon
2.Subjects with evidence of severe active Crohn's Disease and/or,
structuring and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications
3.Subjects who do not have a negative stool analysis, within the 30 days
prior to Visit 1
4.Subjects who have been screened/or enrolled in this study previously
within the last 6 months


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's Disease
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Entocort
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Primary Outcome(s)
Main Objective: to investigate the safety of Entocort (budesonide) in a Paediatric
population treated for mild to moderate Crohn's disease
Primary end point(s): Safety measures such as adverse events, GCS-related side effects, HPAaxis measurement, laboratory test results and vital signs will be listed
and summarized descriptively, with summaries including all subjects
who received at least one dose of study treatment. Summaries will be
produced by all patients and by dose group (6 mg or 9 mg).
Secondary Objective: To characterize the disease activity in the trial population before and
after treatment through the paediatric Crohn's Disease Activity Index
(PCDAI); Patient reported outcomes: Quality of Life with Entocort EC
treatment based on a subject questionnaire (IMPACT 3)
Timepoint(s) of evaluation of this end point: end of 8 week treatment period
Secondary Outcome(s)
Secondary end point(s): NA
Timepoint(s) of evaluation of this end point: NA
Secondary ID(s)
2011-003743-22-DE
D9422C00001
Source(s) of Monetary Support
ASTRAZENECA
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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