Clinical trial NCT01498497: A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021
Official title: 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]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-12-23
Enrollment: 14
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received study drug and completed the PR-021 study (Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Morning serum cortisol (change from baseline measure)
timeFrame: Baseline, Week 8, Week 16, and Week 24
measure: Standard safety laboratory tests (change from baseline measure)
timeFrame: Baseline, Week 8, Week 16, and Week 24
measure: Treatment-emergent adverse events collection (change from baseline measure)
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: Physical examination and vital signs collection (change from baseline measure)
timeFrame: Baseline, Week 8, Week 16, and Week 24
Secondary outcomes:
measure: Esophagoduodenoscopy with multiple biopsies
timeFrame: Week 24
measure: Patient reported outcomes and physician global assessment
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Center for Digestive Health
state: Georgia
city: Chicago
country: United States
facility: Northwestern University School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Mays Landing
country: United States
facility: South Jersey Pediatric Gastroenterology
state: New Jersey
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Northwestern University School of Medicine
name: Ikuo Hirano, MD
role: PRINCIPAL_INVESTIGATOR
References: