Offered by: Nemours
Location: Delaware Valley
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, Inclusive
What is the trial about?
This study is being done to see if a medicine that is used to treat Crohn’s disease in adults can help treat flares Crohn’s disease in children.
Who can participate?
Children between 5 and 17 years old who have are having a flare of their Crohn’s disease may be able to be in this study. Children that participate in this study must be able to swallow whole capsules without difficulties.
What is involved?
This research study is being done to gain more information, knowledge, and understanding about using a type of steroid in children with Crohn’s disease. Crohn’s disease is a chronic (ongoing) disorder that both adults and children can get. It causes inflammation of the digestive system, also called the GI tract. It is possible for Crohn’s disease to involve any area of the GI tract, but most often causes problems in the small intestine where nutrients are absorbed. Crohn’s disease is often treated by trying to control the inflammation with medicines like steroids. Traditional forms of these medicines can have side effects all over the body when they are taken for long periods of time like they are during treatment of Crohn’s disease. This study is testing a different formulation of a steroid that is designed to stay in the GI tract longer so that there are fewer effects on parts of the body that are not affected by Crohn’s disease.
Contact Nemours Clinical Trials
Trial Name: 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, Inclusive