At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 318 enrolled
Drug / intervention
Oral Budesonide Suspension (OBS) +1 moredrug
Likely dose
Oral Budesonide Suspension (OBS) 0.2 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study
In Brief
A Phase 3 clinical trial evaluating Oral Budesonide Suspension (OBS) and Placebo for Eosinophilic Esophagitis (EoE). Completed, enrolled 318 participants across 77 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEosinophilic Esophagitis (EoE)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartDec 2015
Primary CompletionJan 2019
Study CompletionFeb 2019
TodayJul 2026
First PostedNov 16, 2015
Enrollment StartDec 7, 2015
Primary CompletionJan 24, 2019
Study CompletionFeb 15, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.6 years ago
Interventions
Oral Budesonide Suspension (OBS)drug
Oral Budesonide Suspension (OBS) 10 milliliter (ml) of 0.2 milligram per milliliter (mg/ml) twice daily up to 16 weeks.
Placebodrug
Oral dose of 10 ml of placebo matched with the experimental drug.