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Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis
NCT01386112 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01386112
The ClinicalTrials.gov registry entry for NCT01386112 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01386112 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Georgia, Illinois, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01386112?
The interventions under investigation include: placebo (DRUG), EUR-1100 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01386112?
This trial is sponsored by Forest Laboratories, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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