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COMPLETED Phase 2

OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

NCT01642212 · View on ClinicalTrials.gov ↗

Study Summary

This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

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

FieldValue
Enrollment Target 93 participants
Start Date 2012-07-23
Est. Completion 2014-10-30
Phase Phase 2

Sponsor

Shire

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01642212

The ClinicalTrials.gov registry entry for NCT01642212 describes a study currently listed as completed. It is categorized as Phase 2, 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 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 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 (EoE) 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: NCT01642212 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Illinois, California, 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01642212?

The interventions under investigation include: Placebo (DRUG), Oral Budesonide Suspension (MB-9) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01642212?

This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial