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

Padagis

Status and phase

Completed

Phase 3

Conditions

Crohn's Disease

Treatments

Drug: Entocort

Study type

Interventional

Funder types

Industry

Identifiers

NCT01453946

D9422C00002

Details and patient eligibility

About

A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.

Full description

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

Enrollment

55 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

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.