A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Respon… (NCT02605837) | Clinical Trial Compass
CompletedPhase 3
A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved
United States318 participantsStarted 2015-12-07
Plain-language summary
A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the histologic response and determine if any reduction in dysphagia is achieved.
Who can participate
Age range11 Years – 55 Years
SexALL
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Inclusion Criteria
* Participants is able to provide written informed consent (participant, parent or legal guardian, and, as appropriate, participant assent) to participate in the study before completing any study-related procedures.
* Participant is male or female aged 11-55 years, inclusive, at time of consent.
* Participant has histologic evidence of eosinophilic esophagitis (EoE) with a peak eosinophil count of greater than or equal to (\>=) 15/ high-powered field (HPF), from 2 of 3 (proximal, mid-, and/or distal) levels of the esophagus at the screening endoscopy.
* Participant has a history of clinical symptoms of esophageal dysfunction (for example, eating problems, abdominal pain, heartburn, dysphagia, vomiting, food impaction, weight loss) intermittently or continuously at screening (Visit -1).
* Participants must have experienced dysphagia (response of "yes" to question 2 on Dysphagia Symptom Questionnaire \[DSQ\]) on a minimum of 4 days and completed the DSQ on \>= 70 percent (%) of days in any 2 consecutive weeks of the screening period and in the last 2 weeks prior to the baseline visit (Visit 1).
* Participant must not have PPI-responsive EoE based on esophageal biopsies performed after the patient has been on at least 8 weeks of high-dose PPI therapy (high-dose therapy refers to the total daily dose, which may have been administered as a once or twice daily dosing regimen). This may occur at the time of the qualifying esophagogastroduodenoscopy (EGD) (in whic…
What they're measuring
1
Number of Participants With Histologic Response at the Final Treatment Period Evaluation (Week 16)
Timeframe: Week 16
2
Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16)