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

• Register: EUCTR
• Last refreshed on: 23 February 2015
• Main ID: EUCTR2011-003742-40-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 as a Maintenance Treatment for 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 as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003742-40
• 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

Countries of recruitment

Canada, Germany, Italy, Poland, United States

Contacts

• Affiliation: AstraZeneca Clinical Study Information

• 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. 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 (PCDAI = 10 confirms that the subject is in clinical remission.).
3. 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: 50
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
11. Subjects who have been screened/or enrolled in this study previously within the last 30 days.
13. Subjects who have been dosed in this study previously.
14. 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.
Initiation of azathioprine or 6-MP less than 3 months prior to study start or during the treatment phase of the trial is prohibited.
15. 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. Initiation of 5 aminosalicylates less than 2 weeks prior to study start or during treatment phase of study is prohibited.
16. 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.
17. Subjects taking antibiotics for Crohn’s disease (e.g., ciprofloxan) should be on stable doses 2 weeks prior to study start. Initiation of antibiotics for Crohn’s disease less than 2 weeks prior to study start or during treatment phase of the study is prohibited.
18. Subjects taking erythromycin and other macrolide antibiotics within 7 days of enrollment.
19. 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.
20. 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 (D9422C00001) 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



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: 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™ EC (budesonide) in a paediatric mild to moderate Crohn’s disease population for maintenance of clinical remission

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 at the 6 mg dose.

Timepoint(s) of evaluation of this end point: at the end of the 12-week treatment period

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)

Secondary ID(s)

D9422C00002

Source(s) of Monetary Support

AstraZeneca AB