Kids' obesity may change how acid reflux drugs work
NCT ID NCT04248335
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how obesity affects the way children's bodies process common acid reflux medications like lansoprazole and pantoprazole. Researchers gave a single dose of these drugs to 76 children aged 6-21, both with and without obesity, and measured how long the drugs stayed in their blood. The goal was to understand if obesity changes drug clearance and dosing needs, which could lead to safer, more effective use in kids.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lansoprazole, Pantoprazole, Midazolam
- What this could lead to
- If successful, this could help doctors prescribe more accurate doses of acid reflux drugs for children with obesity.
- What could go wrong
- This is a small, completed study focused on measuring drug levels, not testing a new treatment. Results may not apply to all children or lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
76 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Dec 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 21 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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., erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, ketoconazole) or induce (e.g., oxcarbazepine, carbamazepine, phenytoin, phenobarbital, St. John's Wort, rifampin, rifapentine) or CYP3A4 activity in the last 7 days. * Unable to have blood drawn for the screening lab tests * Unable or unwilling to fast overnight prior to the study session * Unable to have blood drawn for the screening lab tests * If taking lansoprazole or pantoprazole for clinical purposes, unable or unwilling to abstain from that PPI for 3 days prior to PK visit when the PPI is not the same as the study drug for that PK visit * Metal in the body or any foreign bodies that precludes MRI sequencing * Claustrophobia * Exceeds 500lbs or 227 kg in Body Weight * Demonstrated adverse reaction to previous pantoprazole or PPI exposure * Impaired hepatic activity as determined by routine liver function testing and defined as values ≥ 5 times the age-specific upper limit of normal (ULN) for AST, ALT, total bilirubin \>2.0mg/dl, alkaline phosphatase ≥ 5 times the age-specific ULN * Impaired renal function defined as creatinine ≥ 3 times the age-specific ULN * Females of child-bearing age who are pregnant or breast-feeding * Any known infection with hepatitis B, C, or human immunodeficiency virus (HIV)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Mercy Kansas City
Kansas City, Missouri, 64108, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a less invasive reflux surgery match the standard one?