A Six Month, Safety Follow-up Study in Eosinophilic Esoph... | NCT01498497

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

NCT01498497

Sponsor

Forest Laboratories

Status

Completed

Last Update Posted

Feb 9, 2017Estimated

Enrollment

14Actual

Phase

Not provided

Conditions

Eosinophilic Esophagitis

Interventions

EUR-1100
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Dec 16, 2011

First Submission Date that Met QC Criteria

Dec 21, 2011

First Posted Date

Dec 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2017

Last Update Posted Date

Feb 9, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Label	Type	Description	Intervention Names
PR-021 Eosinophilic Esophagitis (EoE) Subjects		Subjects who received study drug and completed PR-021 study	Drug: EUR-1100 Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
EUR-1100	Drug		PR-021 Eosinophilic Esophagitis (EoE) Subjects
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morning serum cortisol (change from baseline measure)		Baseline, Week 8, Week 16, and Week 24
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
Treatment-emergent adverse events collection (change from baseline measure)		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Physical examination and vital signs collection (change from baseline measure)		Baseline, Week 8, Week 16, and Week 24

Secondary Outcomes

Measure	Description	Time Frame
Esophagoduodenoscopy with multiple biopsies		Week 24
Patient reported outcomes and physician global assessment		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

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)

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Children's Center for Digestive Health		Atlanta	Georgia	30342	United States
Northwestern University School of Medicine

ID	Term
D004941	Esophagitis
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases