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

Eosinophilic Esophagitis Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498497
• Other study ID #: PR-022
• Status: Completed
• Phase: N/A
• First received: December 16, 2011
• Last updated: February 8, 2017
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: February 2017
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• EUR-1100

• Placebo

Locations

Country	Name	City	State
United States	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	South Jersey Pediatric Gastroenterology	Mays Landing	New Jersey
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning serum cortisol (change from baseline measure)		Baseline, Week 8, Week 16, and Week 24
Primary	Standard safety laboratory tests (change from baseline measure)	Hematology, serum chemistry, liver function tests, urinalysis, urine chemistry	Baseline, Week 8, Week 16, and Week 24
Primary	Treatment-emergent adverse events collection (change from baseline measure)		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Primary	Physical examination and vital signs collection (change from baseline measure)		Baseline, Week 8, Week 16, and Week 24
Secondary	Esophagoduodenoscopy with multiple biopsies		Week 24
Secondary	Patient reported outcomes and physician global assessment		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24