Skip to main content
OpenTrials
Completed

NCT Number: NCT01498497

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

12 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Center for Digestive Health, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUR-1100

Drug

Placebo

Drug

Primary outcomes

  1. Morning serum cortisol (change from baseline measure)

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

  2. Standard safety laboratory tests (change from baseline measure)

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

    Hematology, serum chemistry, liver function tests, urinalysis, urine chemistry

  3. 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

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

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

Secondary outcomes

  1. Esophagoduodenoscopy with multiple biopsies

    Time frame: Week 24

  2. Patient reported outcomes and physician global assessment

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

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study 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]

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 23, 2011
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.