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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00458614 |
The disposition of a number of drugs has been reported to be altered in patients with Cystic Fibrosis (CF). Changes in pharmacokinetic parameters observed included increased volumes of distribution and increased clearance of renally eliminated drugs. The purpose of this this study is to characterize the pharmacokinetics of IV lansoprazole and its metabolites in normal healthy children and children with Cystic Fibrosis (CF) ages 2 to < 10 years. It is suspected that children with CF will have a more rapid clearance as compared to healthy children.
Condition | Intervention | Phase |
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Cystic Fibrosis |
Drug: Lansoprazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Lansoprazole Disposition in Young Children With Cystic Fibrosis |
Estimated Enrollment: | 18 |
Study Start Date: | June 2006 |
Study Completion Date: | April 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Cystic fibrosis (CF) impacts 1:2500 Caucasian newborns and results from a defect in the cystic fibrosis transmembrane conductance regulator chloride channel (CFTR) responsible for electrolyte regulation. Between 25 to 81% of the CF population have gastro-esophageal reflux disease (GERD), and proton pump inhibitors (PPIs) are frequently prescribed for this condition. Moreover, PPIs are commonly used in patients with CF to allow for better gastric acid stabilization so that pancreatic enzyme efficacy is optimized and nutritional status is improved. Lansoprazole is a PPI that is widely used for acid-related disorders including GERD.
The disposition of a number of drugs has been reported to be altered in CF. Changes in pharmacokinetic parameters observed in patients with CF include increased volumes of distribution and increased clearance of renally eliminated drugs. To date, the pharmacokinetics of PPIs in patients with CF have not been characterized.
This study is a pilot study to evaluate and compare the pharmacokinetics of a single dose of IV lansoprazole in CF and normal children 2 to < 10 years of age. A goal of 12 evaluable subjects ranging from 2 to < 10 years of age including both males and females with CF ∆F508 genotype will be recruited from CF clinic or inpatient. As a comparison group, six evaluable subjects who are normal, healthy children of similar demographic profile (age, gender, and race) will be recruited.
After informed consent/assent is obtained, screening procedures will be completed within 30 days of study participation. The pre-study screen includes an age-appropriate physical exam, medical history (current medication/herbal use), vital signs (non-crying sitting blood pressure and heart rate), height, weight, AST, ALT, and CBC. Subjects will be studied during a current hospitalization or scheduled for an approximately 12-hour study visit.
Ages Eligible for Study: | 2 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Arkansas Children's Hospital Little Rock | |
Little Rock, Arkansas, United States, 72202 |
Principal Investigator: | Holly D Maples, Pharm.D. | University of Arkansas |
Study ID Numbers: | PPRU-10840 |
Study First Received: | April 9, 2007 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00458614 History of Changes |
Health Authority: | United States: Federal Government |
Cystic Fibrosis |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Lansoprazole |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Fibrosis Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions Digestive System Diseases Pathologic Processes Cystic Fibrosis |
Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Therapeutic Uses Anti-Ulcer Agents Pancreatic Diseases Infant, Newborn, Diseases Lansoprazole |