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NCT02605837 · ClinicalTrials.gov registry record · Phase 3
A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 318
- Enrollment target
NCT02605837: Completed Phase 3 study, sponsored by Shire.
NCT02605837 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 318 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02605837, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 318 participants
- Enrollment target
Study 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.
Primary Outcome
Histologic response was defined as a peak eosinophil count of less than or equal to (\<=) 6/ high-powered field (HPF) across all available esophageal levels at final treatment period evaluation (Week 16). Histologic response after 12 weeks of double blind treatment at Week 16 was reported.
Interventions
- DRUG Placebo
- DRUG Oral Budesonide Suspension (OBS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2015-12-07 |
| Est. Completion | 2019-02-15 |
| Phase | Phase 3 |
What the finished NCT02605837 record still lists
NCT02605837 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02605837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02605837 about?
NCT02605837 is a clinical study titled "A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved". A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the histologic response and determine if any reduction in dysphagia is achieved.
What is the current status of trial NCT02605837?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 318 participants. The study started on 2015-12-07. Estimated completion is 2019-02-15.
What interventions are being tested in trial NCT02605837?
The interventions under investigation include: Placebo (DRUG), Oral Budesonide Suspension (OBS) (DRUG).
Who is sponsoring clinical trial NCT02605837?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02605837's enrollment target sits among peer trials
318 1087th of 2000 higher than 912 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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