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Trial record 1 of 1 for:    NCT02186652
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PK Study With Pantoprazole in Obese Children and Adolescents (PAN01)

This study is ongoing, but not recruiting participants.
The EMMES Corporation
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center Identifier:
First received: July 3, 2014
Last updated: August 12, 2016
Last verified: August 2016
Multicenter, comparative single-dose pharmacokinetic (PK) study

Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: Pantoprazole
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Pharmacokinetic Analysis in obese children after one single oral dose of Pantoprazole. The PK parameters for pantoprazole will be measured from Cmax, Tmax, Ka, Kel, AUC, VDss/F & CL/F [ Time Frame: up to 12 hours ]
    The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing.

Secondary Outcome Measures:
  • The CYP2C19 genotype and its association with CYP2C19 phenotype (PK) will be measured with the analysis of a blood sample [ Time Frame: 12 hours ]
    At screening a 1.0 ml venous blood sample will be placed into a tube for CYP2C19 genotyping. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing to better characterize the drug disposition profile in those with two non-functional alleles.

Estimated Enrollment: 40
Study Start Date: July 2014
Estimated Study Completion Date: July 2017
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pantoprazole Drug: Pantoprazole

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.

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Participant is between 6 and 17 (inclusive) years of age at the time of consent
  2. BMI ≥95th percentile
  3. Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:

    1. clinical symptoms consistent with GERD as determined by the investigator
    2. a diagnosis of erosive esophagitis by endoscopy
    3. esophageal biopsy with histopathology consistent with reflux esophagitis
    4. abnormal pH-metry consistent with reflux esophagitis
    5. other test result consistent with GERD
  4. 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 Criteria:

  1. Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
  2. 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
  3. Consumption of food after midnight on the day of the baseline visit
  4. Symptomatic asthma
  5. Type I diabetes
  6. History of adverse reaction to PPI
  7. 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
  8. Serum creatinine ≥2.0 mg/dL
  9. For females of childbearing potential, a positive pregnancy test result
  10. Known infection with hepatitis B, C, or HIV
  11. Any other condition that, in the opinion of the principal investigator, makes participation unadvised or unsafe.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02186652

United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72202
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Phillip Brian Smith
The EMMES Corporation
Principal Investigator: Phillip B Smith, MD Duke Clinical Research Institute
  More Information

Responsible Party: Phillip Brian Smith, Principal Investigator, Duke University Medical Center Identifier: NCT02186652     History of Changes
Other Study ID Numbers: Pro00048765
Study First Received: July 3, 2014
Last Updated: August 12, 2016

Keywords provided by Duke University:

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017