Clinical Trials Directory

Trials / Completed

CompletedNCT01453946

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
55 (actual)
Sponsor
Padagis LLC · Industry
Sex
All
Age
5 Years – 17 Years
Healthy volunteers
Not accepted

Summary

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

Detailed 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

Conditions

Interventions

TypeNameDescription
DRUGEntocortEntocort capsules, taken orally, 6 mg daily.

Timeline

Start date
2011-12-01
Primary completion
2014-02-01
Completion
2014-02-01
First posted
2011-10-18
Last updated
2022-01-06
Results posted
2015-06-19

Locations

19 sites across 5 countries: United States, Canada, Germany, Italy, Poland

Source: ClinicalTrials.gov record NCT01453946. Inclusion in this directory is not an endorsement.