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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01498497
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Forest Laboratories

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.

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Drug: EUR-1100 Drug: Placebo

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : January 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
PR-021 Eosinophilic Esophagitis (EoE) Subjects
Subjects who received study drug and completed PR-021 study
Drug: EUR-1100
Drug: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01498497

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United States, Georgia
Children's Center for Digestive Health
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern University School of Medicine
Chicago, Illinois, United States, 60611
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
South Jersey Pediatric Gastroenterology
Mays Landing, New Jersey, United States, 08330
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Forest Laboratories
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Principal Investigator: Ikuo Hirano, MD Northwestern University School of Medicine

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Responsible Party: Forest Laboratories Identifier: NCT01498497    
Other Study ID Numbers: PR-022
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases