Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Eosinophilic Esophagitis
In brief
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.
Key facts
- Study ID
- NCT01386112
- Run by
- Forest Laboratories
- People needed
- 24
- Starts
- 2011-09-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2012-11-02
Who can join
Age: 12 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Center for Digestive Health — Atlanta, Georgia, United States
- Northwestern University School of Medicine — Chicago, Illinois, United States
- Riley Hospital for Children — Indianapolis, Indiana, United States
- Mayo Clinic — Rochester, Minnesota, United States
- South Jersey Pediatric Gastroenterology — Mays Landing, New Jersey, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- O&O Alpan LLC Center for Clinical Trials — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.