Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis - Full Text View

Sponsor:	Meritage Pharma, Inc.
Information provided by:	Meritage Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT00762073

Purpose

This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for clinical symptom assessment and safety evaluation (including adverse events and vital signs). All study treatments (active drug and placebo) will be administered orally twice daily during the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.

Condition	Intervention	Phase
Eosinophilic Esophagitis (EoE)	Drug: budesonide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Oral Viscous Budesonide Suspension (MB-7) in Subjects With Eosinophilic Esophagitis: A Randomized, Placebo-Controlled, Dose-Ranging Study in Children and Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Children's Health

Drug Information available for: Budesonide

U.S. FDA Resources

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

Primary Outcome Measures:

Percentage reduction in the eosinophilic esophagitis, Clinical Symptom Score and Final Treatment Evaluation, peak eosinophil count from the esophageal biopsies. [ Time Frame: 12-week course of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: budesonide oral suspension
2: Experimental Low Dose Group	Drug: budesonide oral suspension
3: Experimental Medium Dose Group	Drug: budesonide oral suspension
4: Experimental High Dose Group	Drug: budesonide oral suspension

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects between the ages of 2-18 years, inclusive
History of clinical symptoms of esophageal dysfunction intermittently or continuously
Histologic evidence of EoE with a peak eosinophil count of greater than or equal to 20 eosinophils per HPF, from two or more levels of the esophagus, within six weeks prior to the Baseline Visit
At the Baseline Visit, subjects must have symptoms with a total EoE Clinical Symptom Score of greater than or equal to 3
Willingness and ability to continue the dietary therapy, environmental therapy, and/or medical regimens (including gastric acid suppression, if any) in effect at the Screening Visit
Females of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) prior to randomization into the study and sexually active subjects must agree to continue acceptable birth control measures throughout the duration of the study
Written informed consent (parent or legal guardian) and, as appropriate, subject assent

Exclusion Criteria:

Current use of immunomodulatory therapy (or anticipated use within 12 weeks following the Baseline Visit)
Diagnosis of inflammatory bowel disease
Chronic viral infection or immunodeficiency condition (current)
Use of swallowed topical corticosteroids for EoE in the 1 month prior to the biopsy required for entrance to this study or at any time between the biopsy and the Baseline Visit
Use of systemic (oral or parenteral) corticosteroid within 1 month prior to the biopsy required for entrance to this study or at any time between the biopsy and the Baseline Visit
Morning plasma cortisol level below the lower limit of normal (per Central Laboratory reference range) at the Screening Visit
Upper gastrointestinal bleeding within 1 month prior to the Screening Visit or between the Screening Visit and Baseline Visit
Current use of anticoagulants
Current disease of the gastrointestinal tract aside from the current EoE diagnosis
Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
Evidence of active infection with Helicobacter pylori
Evidence of unstable asthma or changes in asthma or allergic rhinitis therapy within 1 month prior to the biopsy required for entrance to this study
Any female who is pregnant, who is planning to become pregnant, or who is breast-feeding
Current evidence or history of hypersensitivity or idiosyncratic reaction to budesonide or any other ingredients of the study medication
Current evidence of oropharyngeal or esophageal candidiasis
Receipt of an investigational drug within 30 days prior to the biopsy required for entrance to this study
Any condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the subject or successful conduct of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762073

Contacts

Contact: Joanne Vitanza, M.D.

858-436-1660

vitanza@meritagepharma.com

Locations

United States, Arizona
Phoenix Children's Hospital	Recruiting
Phoenix, Arizona, United States, 85006
Principal Investigator: Mitchell Shub, MD
United States, California
Stanford University Medical Center	Recruiting
Palo Alto, California, United States, 94305
Principal Investigator: Kari Nadeau, MD, PhD
Children's Hospital of Orange County	Recruiting
Orange, California, United States, 92868
Principal Investigator: Mark H. Ellis, MD, MPH
Rady Children's Hospital	Recruiting
San Diego, California, United States, 92123
Principal Investigator: Mamata Sivagnanam, MD
United States, Colorado
The Children's Hospital	Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: David M. Fleischer, MD
United States, Georgia
Children's Center for Digestive Healthcare	Recruiting
Atlanta, Georgia, United States, 30342
Principal Investigator: Jeffrey Lewis, MD
Emory University-Emory Children's Center	Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Benjamin D Gold, MD
United States, Illinois
Center for Children's Digestive Health	Recruiting
Park Ridge, Illinois, United States, 60068
Principal Investigator: Thirumazhisai S. Gunasekaran, MD
Children's Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60614
Principal Investigator: Barry Wershil, MD
United States, Indiana
Riley Hospital for Children	Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Sandeep K Gupta, MD
United States, Massachusetts
Tufts Medical Center	Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Peter Ngo, MD
Children's Hospital Boston	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Samuel Nurko, MD
United States, Nebraska
The Center for Human Nutrition	Recruiting
Omaha, Nebraska, United States, 68105
Principal Investigator: Laurel L Prestridge, MD
United States, Nevada
Pediatric Gastroenterology and Nutrition Associates	Recruiting
Las Vegas, Nevada, United States, 89109
Principal Investigator: Howard Baron, MD
United States, New Jersey
South Jersey Pediatric Gastroenterology	Recruiting
Mays Landing, New Jersey, United States, 08330
Principal Investigator: John Tung, MD
United States, Pennsylvania
Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Terri Faye Brown-Whitehorn, MD
United States, South Carolina
Children's Center for Digestive Health	Recruiting
Greenville, South Carolina, United States, 29615
Principal Investigator: Jonathan Markowitz, MD
United States, Virginia
Virginia Commonwealth University, Medical College of Virginia	Recruiting
Richmond, Virginia, United States, 23219
Principal Investigator: Anne-Marie A. Irani, MD
Carilion Pediatric Gastroenterology	Recruiting
Roanoke, Virginia, United States, 24013
Principal Investigator: Michael Hart, MD
Children's Hospital of the King's Daughters	Recruiting
Norfolk, Virginia, United States, 23507
Principal Investigator: Gregory E Kobak, MD

Sponsors and Collaborators

Meritage Pharma, Inc.

More Information

No publications provided

Responsible Party:	Meritage Pharma, Inc. ( Malcolm Hill, Pharm.D. / Chief Scientific Officer )
Study ID Numbers:	MPI-101-01
Study First Received:	September 29, 2008
Last Updated:	September 29, 2009
ClinicalTrials.gov Identifier:	NCT00762073 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Meritage Pharma, Inc.:

eosinophilic esophagitis

Additional relevant MeSH terms:

Esophagitis
Anti-Inflammatory Agents
Respiratory System Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Hormones

Glucocorticoids
Pharmacologic Actions
Digestive System Diseases
Autonomic Agents
Therapeutic Uses
Esophageal Diseases
Peripheral Nervous System Agents
Gastroenteritis
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 20, 2009