Safety Study of Entocort for Children With Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 17 January 2022
• Main ID: NCT01444092
• Date of registration: 28/09/2011
• Prospective Registration: Yes
• Primary sponsor: Padagis LLC
• Public title: Safety Study of Entocort for Children With Crohn's Disease
• 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: November 2011
• Target sample size: 123
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01444092
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, Germany, Italy, Poland, United States

Contacts

• Name: Stanley Cohen, MD
• Affiliation: Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA and Emory University School of Medicine, Atlanta, Georgia, USA

• Name: Stefan Eklund, MD
• Affiliation: AstraZeneca Pharmaceuticals, Mölndal, Sweden

Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Entocort

Primary Outcome(s)

Adverse Event [Time Frame: 12 weeks]

Secondary Outcome(s)

PCDAI [Time Frame: Baseline to 8 weeks]

IMPACT 3 [Time Frame: Baseline to 8 weeks]

Secondary ID(s)

D9422C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/08/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01444092