CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 55 enrolled
Drug / intervention
Entocortdrug
Likely dose
Entocort 6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01453946
NCT01453946Phase 3Completed

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

Padagis LLC·interventional·Posted Oct 18, 2011·Updated Jan 6, 2022

In Brief

A Phase 3 clinical trial evaluating Entocort for Crohn's Disease. Completed, enrolled 55 participants across 19 sites in 5 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesCanada, Germany, Italy, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2011
Enrollment StartDec 1, 2011
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.7 years ago

Interventions

Entocortdrug

Entocort capsules, taken orally, 6 mg daily.