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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 January 2022
• Main ID: NCT01453946
• Date of registration: 14/10/2011
• Prospective Registration: Yes
• Primary sponsor: Padagis LLC
• Public title: Safety and Maintenance 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 as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
• Date of first enrolment: December 2011
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01453946
• 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

• 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.

- 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.



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: 16 weeks]

Secondary Outcome(s)

IMPACT 3 [Time Frame: 12 weeks]

PCDAI [Time Frame: 12 weeks]

Secondary ID(s)

D9422C00002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/06/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01453946