PK Study With Pantoprazole in Obese Children and Adolescents

Completed · Phase 1

Conditions studied: Gastroesophageal Reflux Disease

In brief

Multicenter, comparative single-dose pharmacokinetic (PK) study

Key facts

Study ID

NCT02186652

Run by

Phillip Brian Smith

People needed

41

Starts

2014-06-04

Expected to finish

2015-09-13

Last updated by the study team

2019-09-17

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is between 6 and 17 (inclusive) years of age at the time of consent
• BMI ≥95th percentile
• Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:
• clinical symptoms consistent with GERD as determined by the investigator
• a diagnosis of erosive esophagitis by endoscopy
• esophageal biopsy with histopathology consistent with reflux esophagitis
• abnormal pH-metry consistent with reflux esophagitis
• other test result consistent with GERD
• Written informed consent from the parent or legally authorized representative/guardian and participant assent per local IRB recommendation of age-appropriate consent and assent requirements

You may not qualify if…

• Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
• Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate, valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within seven days prior to dose of study drug
• Consumption of food after midnight on the day of the baseline visit
• Symptomatic asthma
• Type I diabetes
• History of adverse reaction to PPI
• Impaired hepatic activity as defined as any of the following: AST ≥150 IU/L, ALT ≥150 IU/L, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 IU/L
• Serum creatinine ≥2.0 mg/dL
• For females of childbearing potential, a positive pregnancy test result
• Known infection with hepatitis B, C, or HIV
• Any other condition that, in the opinion of the principal investigator, makes participation unadvised or unsafe.

Where it is running

• University of Arkansas — Little Rock, Arkansas, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• East Carolina University — Greenville, North Carolina, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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