Status:
COMPLETED
Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
2-10 years
Phase:
PHASE1
Brief Summary
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 an...
Detailed Description
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 regulati...
Eligibility Criteria
Inclusion
- Subjects who have the diagnosis of CF with the ∆F508 genotype (hetero- or homozygous) or who are normal and healthy as determined by the principal investigator, have in the past year received a H2 receptor antagonist, PPI, or antacid, and do not meet any of the exclusion criteria.
- Subjects of either gender and all races and ethnicity age 2 to \< 10 years.
- Written informed consent from parent or guardian who has sufficient intellectual capacity to understand the study and adhere to the procedures and as applicable (i.e., subjects ≥ 7 years of age), subject assent.
Exclusion
- Refusal of informed consent/assent by the parent/caregiver and child \> 7 years of age.
- Body weight less than 10 kg.
- Three or more hospitalizations during the preceding year.
- Severe liver dysfunction (AST \& ALT \> 3 times the upper normal limit).
- Clinically significant (determined by investigator) alterations in hemoglobin and/or hematocrit.
- Pregnancy or lactation.
- Concurrent therapy with agents other than a PPI that are known to be CYP2C19 substrates within 2 weeks of study drug administration
- PPI use within 48 hours of study drug administration.
- Acute change in health status within 72 hours of study drug administration.
- Allergy or hypersensitivity to lansoprazole or to other proton pump inhibitors
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00458614
Start Date
June 1 2006
End Date
April 1 2007
Last Update
January 11 2011
Active Locations (1)
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1
Arkansas Children's Hospital Little Rock
Little Rock, Arkansas, United States, 72202