NCT01444092

Safety Study of Entocort for Children With Crohn's Disease

A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Padagis LLC · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

A Safety Study using 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 for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Entocort	Entocort capsules, oral

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2011-09-30
• Last updated: 2022-01-06
• Results posted: 2016-08-11

Locations

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