A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021
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]
1 other identifier
observational
14
1 country
6
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2012
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFebruary 9, 2017
February 1, 2017
1.2 years
December 16, 2011
February 8, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Morning serum cortisol (change from baseline measure)
Baseline, Week 8, Week 16, and Week 24
Standard safety laboratory tests (change from baseline measure)
Hematology, serum chemistry, liver function tests, urinalysis, urine chemistry
Baseline, Week 8, Week 16, and Week 24
Treatment-emergent adverse events collection (change from baseline measure)
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Physical examination and vital signs collection (change from baseline measure)
Baseline, Week 8, Week 16, and Week 24
Secondary Outcomes (2)
Esophagoduodenoscopy with multiple biopsies
Week 24
Patient reported outcomes and physician global assessment
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Study Arms (1)
PR-021 Eosinophilic Esophagitis (EoE) Subjects
Subjects who received study drug and completed PR-021 study
Interventions
Eligibility Criteria
Subjects who received study drug and completed the PR-021 study (Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Children's Center for Digestive Health
Atlanta, Georgia, 30342, United States
Northwestern University School of Medicine
Chicago, Illinois, 60611, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
South Jersey Pediatric Gastroenterology
Mays Landing, New Jersey, 08330, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ikuo Hirano, MD
Northwestern University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2011
First Posted
December 23, 2011
Study Start
January 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
February 9, 2017
Record last verified: 2017-02