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NCT01386112 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis
A Phase 1 study of Eosinophilic Esophagitis, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 7
- Study locations
NCT01386112: Completed Phase 1 study of Eosinophilic Esophagitis, sponsored by Forest Laboratories.
NCT01386112 is a Phase 1 study of Eosinophilic Esophagitis that has completed, run by Forest Laboratories. The registered enrollment target is 24 participants, below the 864-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01386112, a Phase 1 study of Eosinophilic Esophagitis, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 7
- Study locations
Study Summary
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by published case series and controlled trials in children and adults, the most widely used drug treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal) action. This study will evaluate the safety and tolerability of orally administered EUR-1100 once or twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.
Conditions Studied
Interventions
- DRUG placebo
- DRUG EUR-1100
Study Locations (7)
Georgia
- Children's Center for Digestive Health - Atlanta
Illinois
- Northwestern University School of Medicine - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Minnesota
- Mayo Clinic - Rochester
New Jersey
- South Jersey Pediatric Gastroenterology - Mays Landing
Pennsylvania
- University of Pennsylvania - Philadelphia
Virginia
- O&O Alpan LLC Center for Clinical Trials - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT01386112 record still lists
NCT01386112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 864-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01386112 lists 7 locations in 7 states (Georgia, Illinois, Indiana).
Frequently Asked Questions
What is clinical trial NCT01386112 about?
NCT01386112 is a clinical study titled "Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis". Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by published case series and con...
What is the current status of trial NCT01386112?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-09. Estimated completion is 2012-10.
What conditions does trial NCT01386112 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis.
What interventions are being tested in trial NCT01386112?
The interventions under investigation include: placebo (DRUG), EUR-1100 (DRUG).
Who is sponsoring clinical trial NCT01386112?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01386112 being conducted?
This trial has 7 study locations across Georgia, Illinois, Indiana, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Eosinophilic Esophagitis
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 NCT01386112's enrollment target sits among peer trials
24 35th of 44 higher than 10 of 44 other Eosinophilic Esophagitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis 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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