Status:
COMPLETED
PK Study With Pantoprazole in Obese Children and Adolescents
Lead Sponsor:
Phillip Brian Smith
Collaborating Sponsors:
The Emmes Company, LLC
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
Brief Summary
Multicenter, comparative single-dose pharmacokinetic (PK) study
Detailed Description
Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (GERD) following administration of an oral dose of pantoprazole.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2015
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02186652
Start Date
June 4 2014
End Date
September 13 2015
Last Update
September 17 2019
Active Locations (4)
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1
University of Arkansas
Little Rock, Arkansas, United States, 72202
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
3
East Carolina University
Greenville, North Carolina, United States, 27834
4
University of Utah
Salt Lake City, Utah, United States, 84108