A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021

Forest Laboratories14 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Eosinophilic Esophagitis

Interventions

EUR-1100DRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Locations (6)

Children's Center for Digestive Health

Atlanta, Georgia, United States

Northwestern University School of Medicine

Chicago, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Mayo Clinic

Rochester, Minnesota, United States

South Jersey Pediatric Gastroenterology

Mays Landing, New Jersey, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Morning serum cortisol (change from baseline measure)

Time frame: 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

Time frame: Baseline, Week 8, Week 16, and Week 24

Treatment-emergent adverse events collection (change from baseline measure)

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Physical examination and vital signs collection (change from baseline measure)

Time frame: Baseline, Week 8, Week 16, and Week 24

Secondary Outcomes

Esophagoduodenoscopy with multiple biopsies

Time frame: Week 24

Patient reported outcomes and physician global assessment

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24