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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00358449 |
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.
Condition | Intervention | Phase |
---|---|---|
Esophagitis Eosinophilic |
Drug: mepolizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Randomized, Double-Blind, Parallel Group Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Mepolizumab (SB240563)(0.55mg/kg, 2.5mg/kg or 10mg/kg) in Pediatric Subjects With Eosinophilic Esophagitis, Aged 2 to 17 Years (Study MEE103219) |
Estimated Enrollment: | 72 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply. Inclusion criteria pertain to all subjects in both cohorts (treatment and observational) unless otherwise stated.
NOTE: If subject is within weight requirements but close to the upper or lower limits at screening and the investigator anticipates that during the study the subject's weight will change a become outside the weight requirements, the subject should be excluded from the study.
To be eligible for entry in the treatment group of the study, a female subject is eligible to enter the study if she is:
The subject has a diagnosis of eosinophilic esophagitis and current evidence on biopsy of isolated eosinophilic esophagitis defined as:
and
•Inadequate response to or intolerant of therapy for eosinophilic esophagitis
The criteria used by the investigator to define inadequate response to or intolerance of therapy for eosinophilic esophagitis will be collected in the CRF.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply. Exclusion criteria pertain to all subjects in both cohorts (treatment and observational) unless otherwise stated.
Current presence, or history of (anytime in the past):
Known evidence of the following infections/infestations:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | MEE103219 |
Study First Received: | July 27, 2006 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00358449 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration |
eosinophilic mepolizumab esophagitis |
Esophagitis Digestive System Diseases Esophageal disorder Gastrointestinal Diseases |
Eosinophilic enteropathy Esophageal Diseases Gastroenteritis |