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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

July 13, 2012
March 25, 2014
July 2012
August 2014   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01642212 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Eosinophilic Esophagitis
  • 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
  • Experimental: Oral Budesonide Suspension
    Taken once or twice daily for up to 40 weeks
    Intervention: Drug: Oral Budesonide Suspension (MB-9)
  • Placebo Comparator: Matching Placebo
    Taken once or twice daily for 20 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
11 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01642212
MPI-101-06
No
Meritage Pharma, Inc.
Meritage Pharma, Inc.
Not Provided
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
Meritage Pharma, Inc.
March 2014

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