Eosinophilic esophagitis (EoE) is a chronic immune system disease characterized by infiltration of certain white blood cells (eosinophils) in the esophagus (food tube) in reaction to foods, allergens, or acid reflux. It can cause inflammation and lead to difficulty swallowing (dysphagia).
Participants sought for a study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the histologic response and determine if any reduction in dysphagia is achieved.
Description: A Phase 3, randomized, double-blind, placebo-controlled trial to study safety and efficacy of the drug oral budesonide suspension (OBS) in adolescent and adult subjects (11 to 55 years of age, inclusive) with eosinophilic esophagitis, which involves a planned 3−6 week screening period, a 16 week treatment period, and a 4 week safety follow-up period.
Study Population: Male and female patients with EoE aged 11 to 55 who meet inclusion criteria.
Study Sponsor: Shire
North Little Rock, Arkansas
Port Orange, Florida
Baton Rouge, Louisiana
What are Phases?
Treatment trials or studies are in four phases:
Phase 1 tests a new drug or treatment in a small group to evaluate its safety, determine a safe dosage range, and identify side effects;
Phase 2 expands the study to a larger group of people to see if it is effective and to further evaluate its safety;
Phase 3 expands the study to an even larger group of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely; and
Phase 4 takes place after the drug or treatment has been licensed and marketed to further evaluate it in the general population.