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NCT01642212 · ClinicalTrials.gov registry record · Phase 2
OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension
A Phase 2 study of Eosinophilic Esophagitis (EoE), sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT01642212: Completed Phase 2 study of Eosinophilic Esophagitis (EoE), sponsored by Shire.
NCT01642212 is a Phase 2 study of Eosinophilic Esophagitis (EoE) that has completed, run by Shire. The registered enrollment target is 93 participants, below the 117-participant average among 10 other Eosinophilic Esophagitis (EoE) trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01642212, a Phase 2 study of Eosinophilic Esophagitis (EoE), has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)
Primary Outcome
Histologic response was defined as a peak eosinophil count \</= 6/high power field (light microscopy) (HPF) across all esophageal levels at the final treatment evaluation (Week 16). An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oral Budesonide Suspension (MB-9)
Study Locations (20)
Illinois
- Northwestern Scool of Medicine - Chicago
- Children's Memorial Hospital - Chicago
- Center for Children's Digestive Health - Park Ridge
California
- Children's Hospital of Orange County - Orange
- UCSD Rady Children's Hospital - San Diego
Indiana
- Indiana University Health University Hospital - Indianapolis
- Riley Hospital for Children - Indianapolis
Massachusetts
- Tufts Medical Center - Boston
- Children's Hospital Boston - Boston
Ohio
- The Cincinnati Center for Eosinophilic Disorders - Cincinnati
- Great Lakes Gastroenterology - Mentor
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- The Children's Hospital - Aurora
Georgia
- Children's Center for Digestive Healthcare - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2012-07-23 |
| Est. Completion | 2014-10-30 |
| Phase | Phase 2 |
What the finished NCT01642212 record still lists
NCT01642212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 117-participant average among 10 other Eosinophilic Esophagitis (EoE) trials with a reported enrollment target (21% lower).
The record links to 1 condition, with Eosinophilic Esophagitis (EoE) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01642212 names 20 study sites across 14 states, led by Illinois, California, Indiana.
Frequently Asked Questions
What is clinical trial NCT01642212 about?
NCT01642212 is a clinical study titled "OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension". This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)
What is the current status of trial NCT01642212?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2012-07-23. Estimated completion is 2014-10-30.
What conditions does trial NCT01642212 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis (EoE).
What interventions are being tested in trial NCT01642212?
The interventions under investigation include: Placebo (DRUG), Oral Budesonide Suspension (MB-9) (DRUG).
Who is sponsoring clinical trial NCT01642212?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01642212 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Eosinophilic Esophagitis (EoE)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01642212's enrollment target sits among peer trials
93 6th of 10 higher than 5 of 10 other Eosinophilic Esophagitis (EoE) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis (EoE) 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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