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:
Meritage Pharma, Inc.
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
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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 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 |
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 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Oral Budesonide Suspension |
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 Sugar Suspension | 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: | 12 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642212
Show 29 Study Locations
Show 29 Study LocationsSponsors and Collaborators
Meritage Pharma, Inc.
Investigators
| 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 |
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: | April 17, 2013 |
| 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 May 19, 2013