Status:
COMPLETED
A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021
Lead Sponsor:
Forest Laboratories
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
12-55 years
Brief 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...
Eligibility Criteria
Inclusion
- Subject completed full participation in Study PR-021 (Subjects discontinued prematurely from PR-021 due to HPA axis suppression will be eligible for study PR-022)
- Written informed consent (parent or legal guardian must sign when applicable) and assent form, if required
- Willing and able to adhere to all study procedures
Exclusion
- Subjects already requiring medications or procedures for the treatment of EoE at the time of enrollment into the follow-up study, such as systemic (oral or parenteral) or inhaled corticosteroids, esophageal dilation, Proton Pump Inhibitors (PPIs) and/or dietary restrictions; in the case of subjects already on PPIs and /or dietary restrictions during Study PR-021, only subjects requiring an increase in dosage of PPIs and/or new dietary restrictions because of worsening of symptoms will be excluded
- Any physical, mental, or social condition, history or concurrent illness or laboratory abnormality that, in the investigator's judgment, might interfere with study procedures or the ability of the subject to adhere to and complete the study
- Contraindication to esophagogastroduodenoscopy (EGD) or esophageal biopsy or narrowing of the esophagus precluding EGD
- Female subjects who are pregnant or breastfeeding
- Participation in a clinical study involving an investigational drug or investigational device
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01498497
Start Date
January 1 2012
End Date
April 1 2013
Last Update
February 9 2017
Active Locations (6)
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1
Children's Center for Digestive Health
Atlanta, Georgia, United States, 30342
2
Northwestern University School of Medicine
Chicago, Illinois, United States, 60611
3
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
4
Mayo Clinic
Rochester, Minnesota, United States, 55905