Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a clinical trial that has completed, run by Forest Laboratories. The registered enrollment target is 14 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01498497
The ClinicalTrials.gov registry entry for NCT01498497 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01498497 reports 0 study locations.
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.