NCT01702701|WithdrawnPhase 3
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Sponsor study identifier
interventional
0
1 country
2
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 20, 2017
Actual (reported)Study Completion
July 20, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 20, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 4, 2012
Actual (reported)October 8, 2012
Actual (reported)July 20, 2017
Actual (reported)July 20, 2017
Actual (reported)Improvement in Dysphagia symptom score
3 month
Improvement in esophageal histology counts of eosinophils/hpf
3 month
patients will receive 10 mg po montelukast daily for 12 weeks.
patients will receive 440mcg fluticasone po bid for 12 weeks
montelukast 10mg po pill q day for 12 weeks
fluticasone 440mcg po q bid x 12 weeks
GI Associates
Milwaukee, Wisconsin, 53226, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Walter Hogan, MD
Medical College of Wisconsin
Nikhil Shastri, MD
Medical College of Wisconsin
0 participants (actual enrollment reported by the registry).
First Submitted
October 4, 2012
First Posted
October 8, 2012
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
Predicting the Response to Montelukast by Genetic Variation in Asthmatics
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 20, 2017
Actual (reported)Study Completion
July 20, 2017
Actual (reported)Last Updated
August 28, 2019
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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