drugset / Trial / NCT01702701

Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

NCT01702701

Phase 3 Withdrawn Medical College of Wisconsin
RandomizedParallel-groupSingle-blindTreatment

Summary

This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective in treating symptoms and histology of EoE when compared to fluticasone. The study will be conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After identification and recruitment all patients will be randomized (provider blinded) to one of two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then undergo a repeat endoscopy to evaluate endoscopic and histologic response.

Timeline

Start
2012-01
Primary completion
2017-07-20
Completion
2017-07-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Other / unclassified 440 ug Oral
Comparator Montelukast Other / unclassified 10 mg Oral