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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Aptalis Pharma
ClinicalTrials.gov Identifier:
NCT01498497
First received: December 16, 2011
Last updated: October 31, 2012
Last verified: August 2012
  Purpose

This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse events and HPA axis 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 Intervention
Eosinophilic Esophagitis
Drug: EUR-1100
Drug: Placebo

Study Type: Observational
Study Design: 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]

Resource links provided by NLM:


Further study details as provided by Aptalis Pharma:

Primary Outcome Measures:
  • Morning serum cortisol (change from baseline measure) [ Time Frame: Baseline, Week 8, Week 16, and Week 24 ] [ Designated as safety issue: Yes ]
  • Standard safety laboratory tests (change from baseline measure) [ Time Frame: Baseline, Week 8, Week 16, and Week 24 ] [ Designated as safety issue: No ]
    Hematology, serum chemistry, liver function tests, urinalysis, urine chemistry

  • 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 ] [ Designated as safety issue: No ]
  • Physical examination and vital signs collection (change from baseline measure) [ Time Frame: Baseline, Week 8, Week 16, and Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Esophagoduodenoscopy with multiple biopsies [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Patient reported outcomes and physician global assessment [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2012
Estimated Study Completion Date: April 2013
Groups/Cohorts Assigned Interventions
PR-021 EoE Subjects
Subjects who received study drug and completed PR-021 study
Drug: EUR-1100 Drug: Placebo

  Eligibility

Ages Eligible for Study:   12 Years to 55 Years
Genders Eligible for Study:   Both
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)

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, 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 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498497

Locations
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
Aptalis Pharma
Investigators
Principal Investigator: Ikuo Hirano, MD Northwestern University School of Medicine
  More Information

No publications provided

Responsible Party: Aptalis Pharma
ClinicalTrials.gov Identifier: NCT01498497     History of Changes
Other Study ID Numbers: PR-022
Study First Received: December 16, 2011
Last Updated: October 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014