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NCT01498497 · ClinicalTrials.gov registry record
A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021
A clinical trial, sponsored by Forest Laboratories.
- Completed
- Registry status
- 14
- Enrollment target
NCT01498497: Completed study, sponsored by Forest Laboratories.
NCT01498497 is a clinical trial that has completed, run by Forest Laboratories. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01498497 has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- 14 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG EUR-1100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-04 |
What the finished NCT01498497 record still lists
NCT01498497 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01498497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01498497 about?
NCT01498497 is a clinical study titled "A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021". 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 Eosinoph...
What is the current status of trial NCT01498497?
This trial is currently completed. The enrollment target is 14 participants. The study started on 2012-01. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01498497?
The interventions under investigation include: Placebo (DRUG), EUR-1100 (DRUG).
Who is sponsoring clinical trial NCT01498497?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
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