OBS in Adolescent and Young Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

This study is currently recruiting participants.

Verified February 2013 by Meritage Pharma, Inc.

Sponsor:

Information provided by (Responsible Party):

Meritage Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT01642212

First received: July 13, 2012

Last updated: April 17, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 13, 2012

Last Updated Date

April 17, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Histologic and Symptom Response [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

The histologic and symptom response to therapy will be evaluated at Week 16.

Original Primary Outcome Measures ^ICMJE

Histologic and Symptom Response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

The histologic and symptom response to therapy will be evaluated at Week 12.

Change History

Complete list of historical versions of study NCT01642212 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

OBS in Adolescent and Young Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

Official Title ^ICMJE

Oral Budesonide Suspension (OBS) in Adolescent and Young Adult Subjects (12-25 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension

Brief Summary

This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

Detailed Description

Eosinophilic Esophagitis (EoE) is an inflammatory disorder of the esophagus and is a recognized clinical entity. Symptoms include feeding problems, heartburn, regurgitation, vomiting, abdominal pain and food impaction. The symptoms of EoE may be similar to gastroesophageal reflux disease (GERD) but do not resolve with gastric acid suppression. EoE is defined histologically as the presence of > 15 intraepithelial eosinophils per high power fields on one or more esophageal biopsy specimens.

This Phase II study is comparing oral budesonide (OBS) to placebo to demonstrate that OBS induces a histologic response and a symptom response using a Dysphagia Symptom Questionnaire over a 16 week course of therapy.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Eosinophilic Esophagitis

Intervention ^ICMJE

Drug: Oral Budesonide Suspension (MB-9)
OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period
Drug: Placebo

Study Arm (s)

Experimental: Oral Budesonide Suspension
Intervention: Drug: Oral Budesonide Suspension (MB-9)
Placebo Comparator: Matching Sugar Suspension
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

August 2014

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and Females, age 12-25
Histologic evidence of EoE
History of clinical symptoms of EoE including dysphagia
Willing to continue with dietary, environmental or medical therapy
Ability to read and understand english
Written Consent

Exclusion Criteria:

Any Medical condition that may compromise the safety of the subjects or interfere with the signs and symptoms of EoE
Use of immunomodulatory therapy
Current use of swallowed corticosteroids
Esophageal strictures,varices or upper GI bleed
Other current diseases of the GI tract
Current viral infection or immunodeficiency condition
Pregnancy
Hypersensitivity to budesonide
History of non compliance

Gender

Both

Ages

12 Years to 25 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01642212

Other Study ID Numbers ^ICMJE

MPI-101-06

Has Data Monitoring Committee

Responsible Party

Meritage Pharma, Inc.

Study Sponsor ^ICMJE

Meritage Pharma, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Peter Ngo, MD	Tufts Children's Medical Center
Principal Investigator:	Howard Baron, MD	Pediatric Gastroenterology & Nutrition Associates
Principal Investigator:	Amir Kagalwalla, MD	Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator:	Jeffrey Lewis, MD	Children's Center for Digestive Healthcare
Principal Investigator:	Jonathan Markowitz, MD	Children's Center for Digestive Health
Principal Investigator:	Samuel Nurko, MD	Children's Hospital Boston
Principal Investigator:	John Tung, MD	South Jersey Pediatric Gastroenterology
Principal Investigator:	John Wo, MD	Indiana University Health University Hospital
Principal Investigator:	Evan Dellon, MD	University of North Carolina, Chapel Hill
Principal Investigator:	T.S. Gunasekaran, MD	Center for Digestive Health
Principal Investigator:	Ikuo Hirano, MD	Northwestern School of Medicine
Principal Investigator:	Sandeep Gupta, MD	Riley Hospital for Children
Principal Investigator:	Brad Pasternak, MD	Phoenix Children's Hospital
Principal Investigator:	Mark Ellis, MD	Children's Hospital Orange County
Principal Investigator:	Anne M Irani, MD	VCU Medical Center
Principal Investigator:	Kathyrn Peterson, MD	University of Utah Healthcare
Principal Investigator:	Gary Falk, MD	University of Pennsylvania
Principal Investigator:	John Leung, MD	Tufts Medical Center
Principal Investigator:	Laurel Prestridge, MD	Boy's Town National Research Hospital
Principal Investigator:	John Russo, MD	The Research Institute at Nationwide Children's Hospital
Principal Investigator:	Michael Hart, MD	Carilion Clinic
Principal Investigator:	Vincent Mukkada, MD	Hasbro Children's Hospital
Principal Investigator:	Michael Vaezi, MD	Vanderbilt University
Principal Investigator:	Rebecca Cherry, MD	UCSD
Principal Investigator:	Robert Kramer, MD	Children's Hospital Colorado
Principal Investigator:	Rayne Grothe, MD	Mayo Clinic
Principal Investigator:	Keith Friedenberg, MD	Great Lakes Gastroenterology
Principal Investigator:	Ron Shey, MD	University of Iowa Hospital
Principal Investigator:	James Franciosi, MD	Nemours Children's Hospital

Information Provided By

Meritage Pharma, Inc.

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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