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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

  Show 23 Study Locations
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:
Eosinophilic Esophagitis
Esophagitis
Digestive System Diseases
Eosinophilia
Esophageal Diseases
Gastroenteritis
Gastrointestinal Diseases
Hematologic Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Leukocyte Disorders
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014