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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Meritage Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01642212
First received: July 13, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Eosinophilic Esophagitis
Drug: Oral Budesonide Suspension (MB-9)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension

Resource links provided by NLM:


Further study details as provided by Meritage Pharma, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Budesonide Suspension
Taken once or twice daily for up to 40 weeks
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
Placebo Comparator: Matching Placebo
Taken once or twice daily for 20 weeks
Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   11 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females, age 11-40
  • 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
  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: NCT01642212

  Hide Study Locations
Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
UCSD Rady Children's Hospital
San Diego, California, United States, 92123
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Georgia
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern Scool of Medicine
Chicago, Illinois, United States, 60611
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Center for Children's Digestive Health
Park Ridge, Illinois, United States, 60068
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
The Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
The Cincinnati Center for Eosinophilic Disorders
Cincinnati, Ohio, United States, 45229
Great Lakes Gastroenterology
Mentor, Ohio, United States, 44060
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Children's Center for Digestive Health
Greenville, South Carolina, United States, 29615
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Utah
University of Utah Healthcare
Salt Lake City, Utah, United States, 84132
United States, Virginia
Carilion Pediatric Gastroenterology
Roanoke, Virginia, United States, 24013
Sponsors and Collaborators
Meritage Pharma, Inc.
Investigators
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 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: 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: John Russo, MD The Research Institute at Nationwide Children's Hospital
Principal Investigator: Michael Hart, MD Carilion Clinic
Principal Investigator: Neal Leleiko, MD Rhode Island 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: David Katzka, MD Mayo Clinic
Principal Investigator: Keith Friedenberg, MD Great Lakes Gastroenterology
Principal Investigator: Ron Schey, MD University of Iowa Hospital
Principal Investigator: Yoram Elitsur, MD University Physician & Surgeons (UP&S)
Principal Investigator: Harvey Tatum, MD Options Health Research, LLC
Principal Investigator: Vincent Mukkada, MD The Cincinnati Center for Eosinophilic Disorders
  More Information

No publications provided

Responsible Party: Meritage Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01642212     History of Changes
Other Study ID Numbers: MPI-101-06
Study First Received: July 13, 2012
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Meritage Pharma, Inc.:
EoE

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
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014