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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: 10 July 2015
Main ID:  EUCTR2011-003743-22-DE
Date of registration: 20/10/2011
Prospective Registration: Yes
Primary sponsor: AstraZeneca AB
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:
Target sample size: 110
Recruitment status: Not Recruiting
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: yes 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: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Canada Germany Italy Poland United States
Contacts
Name:    
Address:  United States
Telephone: 001800236-9933
Email: information.center@astrazeneca.com
Affiliation:  AstraZeneca Clinical Study Information
Name:    
Address:  United States
Telephone: 001800236-9933
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 toxin, 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
9. All subjects must weigh =15 kg at the time of enrolment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 110
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
16. Subjects taking 6-mercaptopurine or azathioprine should be on stable doses for 3 months prior to study start, and should plan on maintaining this stable dose throughout the course of the study
17. Subjects taking 5 aminosalicylates should be on stable doses 2 weeks prior to study start and should plan on maintaining this stable dose throughout the course of the study.
18. Subjects taking Methotrexate should be on stable doses 6 weeks prior to study start and should plan on maintaining this stable dose throughout the course of the study.
19. Subjects taking antibiotics for Crohn’s disease (e.g., ciprofloxan) should be on stable doses 2 weeks prior to study start.
21. Subjects taking Enteral Nutrition therapy for Crohn’s disease should be on stable regimen 2 weeks prior to study start and should plan on maintaining this regimen throughout the course of the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's Disease
Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Intervention(s)

Trade Name: Entocort® Kapseln
Product Name: budesonide
Pharmaceutical Form: Modified-release 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, HPA-axis 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 ID(s)
D9422C00001
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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