Status:
COMPLETED
Pharmacokinetics of Pantoprazole and CYP2C19 Activity in Children and Adolescents With GERD: A Pilot Study
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Obesity
GERD
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
Brief Summary
The World Health Organization has declared childhood obesity to be "one of the most serious public health challenges of the 21st century," (http://www.who.int/dietphysicalactivity/childhood). Given th...
Detailed Description
As the pediatric obesity epidemic continues to rise, obesity-associated pathologic conditions, such as type II diabetes, hypertension and gastroesophageal reflux disease (GERD), become more prevalent,...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and females between 6 and 17 years of age.
- Pediatric patients who have a primary diagnosis of GERD or related symptoms, defined as one or more of the following: clinical symptoms consistent with GERD, a diagnosis of erosive esophagitis by endoscopy, esophageal biopsy with histopathology consistent with reflux esophagitis, abnormal pH probe study consistent with reflux esophagitis, or other test result consistent with GERD.
- Non-obese: 10th - 84th percentile for BMI (50 subjects)
- Overweight: greater than 85th percentile for BMI (50 subjects)
- Provide written assent with parental permission
- Exclusion Criteria
- Inability to have blood drawn for the screening lab tests
- Current therapy with medications known to clinically significantly inhibit or to induce CYP2C19, such as phenytoin, oxcarbazepine, carbamazepine, and rifampicin
- Inability or unwillingness to fast overnight prior to the study session
- Established diagnosis of asthma with evidence of an exacerbation \< 5 days before administration of the study article. Children with asthma that is well controlled on maintenance treatment will be eligible for enrollment to the study
- Existence of metabolic disease
- A demonstrated adverse reaction to previous pantoprazole or PPI exposure
- Impaired hepatic activity as determined by routine liver function testing and defined as values greater than or equal to 3 times the age-specific upper limit of normal (ULN) for AST(aspartate amino transferase), ALT (alanine amino transferase), total bilirubin \>2.0 mg/dl, alkaline phosphatase greater than or equal to 5 times the age-specific ULN
- Impaired renal function defined as greater than or equal to 3 times the age-specific ULN
- For females, a positive urine beta-human chorionic gonadotropin pregnancy test result
- Any known infection with hepatitis B, C, or human immunodeficiency virus (HIV)
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01887743
Start Date
June 1 2013
End Date
October 1 2015
Last Update
December 3 2021
Active Locations (1)
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1
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108