A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021
Public ClinicalTrials.gov record NCT01498497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Six Month Safety Follow-up Study for PR-021 [Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Eosinophilic Esophagitis Subjects]
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the opportunity to better understand the natural course of eosinophilic esophagitis and define the treatment modalities of eosinophilic esophagitis with EUR-1100, such as the need for chronic maintenance or intermittent treatment. All subjects who complete PR-021 will be offered the opportunity to participate in this study. The duration of this follow-up study is six months, during which subjects will visit the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8, Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week 20.
Study identification
- NCT ID
- NCT01498497
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 14 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2012 (Type not available)
- Primary completion
- Apr 2013 (Actual)
- Completion
- Apr 2013 (Actual)
- Last update posted
- Feb 9, 2017
2012 – 2013
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Center for Digestive Health | Atlanta | Georgia | 30342 | — |
| Northwestern University School of Medicine | Chicago | Illinois | 60611 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| South Jersey Pediatric Gastroenterology | Mays Landing | New Jersey | 08330 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01498497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 9, 2017 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01498497 live on ClinicalTrials.gov.