Trials / Completed
CompletedNCT02605837
A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 318 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 11 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oral Budesonide Suspension (OBS) | Oral Budesonide Suspension (OBS) 10 milliliter (ml) of 0.2 milligram per milliliter (mg/ml) twice daily up to 16 weeks. |
| DRUG | Placebo | Oral dose of 10 ml of placebo matched with the experimental drug. |
Timeline
- Start date
- 2015-12-07
- Primary completion
- 2019-01-24
- Completion
- 2019-02-15
- First posted
- 2015-11-16
- Last updated
- 2025-02-19
- Results posted
- 2020-03-16
Locations
77 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02605837. Inclusion in this directory is not an endorsement.