NCT01386112

Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Subjects With Eosinophilic Esophagitis (EoE)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by published case series and controlled trials in children and adults, the most widely used drug treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal) action. This study will evaluate the safety and tolerability of orally administered EUR-1100 once or twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	EUR-1100	Active oral medication
DRUG	placebo	matching placebo

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-06-30
• Last updated: 2012-11-02

Locations

7 sites across 1 country: United States