Phase 3
Completed N=50
Safety and Maintenance Study of Entocort for Children With Crohn's Disease
Crohn's Disease
Source: ClinicalTrials.gov NCT01453946 ↗
Enrolled (actual)
50
Serious AEs
8.0%
Results posted
Jun 2015
Primary outcomePrimary: Adverse Event — 37 Subjects
Summary
A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Event |
37 | — |
| SECONDARY PCDAI |
4.9; 2.0; 6.9 | — |
| SECONDARY IMPACT 3 |
146.6; 1.2; 147.0 | — |
Eligibility 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) 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.
Data sourced from ClinicalTrials.gov (NCT01453946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.