Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis
|ClinicalTrials.gov Identifier: NCT00458614|
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : January 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Lansoprazole||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lansoprazole Disposition in Young Children With Cystic Fibrosis|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
U.S. FDA Resources
- Examine the PK enantiomers of IV lansoprazole and metabolites, in normal children and children with CF.
- To compare the differences in the PK enantiomers of IV lansoprazole and metabolites, between children with CF and normal healthy children
- Examine the PK enantiomers of IV lansoprazole and metabolites in relationship to CYP2C19 genotype in children with CF and normal healthy children
- To assess the effects of ontogeny on IV lansoprazole drug disposition
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458614
|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|