Status:
COMPLETED
Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis
Lead Sponsor:
Shire
Conditions:
Eosinophilic Esophagitis (EoE)
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2010
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00762073
Start Date
January 8 2009
End Date
April 2 2010
Last Update
June 11 2021
Active Locations (20)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85006
2
Children's Hospital of Orange County
Orange, California, United States, 92868
3
Stanford University Medical Center
Palo Alto, California, United States, 94305
4
Rady Children's Hospital
San Diego, California, United States, 92123