Effect of Obesity on Proton Pump Inhibitors (NCT04248335) | Clinical Trial Compass
CompletedPhase 4
Effect of Obesity on Proton Pump Inhibitors
United States150 participantsStarted 2018-07-03
Plain-language summary
This longitudinal study tests the hypothesis that obesity affects drug pharmacology of acid suppression medications in children.
Who can participate
Age range6 Years – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 6-21 years of age
* Obese and non-obese individuals
* BMI ≥10th percentile for age (6-20 years of age)
* BMI ≥18.5 (\>20 years of age)
* Otherwise healthy; or otherwise healthy with diagnosis of GERD, NAFLD, chronic abdominal pain or obesity, according to report of medical history and/or review of the medical record
* Receiving or not receiving pantoprazole or lansoprazole for routine medical care
* MRI Hoop Test Clearance
Exclusion Criteria:
* Unable or unwilling to give written permission/assent/consent
* For PO Study Drug: Any anatomic abnormality of the GI tract as defined by history, PE, or radiographic findings, including Bariatric surgery, Nissen fundoplication or equivalent surgery.
* For IV Study Drug: Any anatomic abnormality of the GI tract as defined by history, PE, or radiographic findings, except Bariatric surgery, Nissen fundoplication or equivalent surgery.
* For subjects undergoing weight management, treatment in the last 7 days with proton pump inhibitors omeprazole, esomeprazole, dexlansoprazole, or grapefruit juice.
* For subjects not undergoing weight management, treatment in the last 7 days with medications known to clinically significantly inhibit (e.g., omeprazole, esomeprazole, fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, trazodone, valproic acid, topiramate) or induce (e.g., phenobarbital, carbamazepine, phenytoin) CYP2C19; and those known at therapeutic doses to significantly inhibit (e.g., erythromyci…