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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 has been completed.
Sponsor:
Collaborator:
The EMMES Corporation
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT02186652
First received: July 3, 2014
Last updated: June 21, 2017
Last verified: June 2017
  Purpose
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: No masking
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 Phillip Brian Smith, Duke University Medical Center:

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
Actual Study Start Date: June 4, 2014
Study Completion Date: September 13, 2015
Primary Completion Date: September 13, 2015 (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.
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02186652

Locations
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
Investigators
Principal Investigator: Phillip B Smith, MD Duke Clinical Research Institute
  More Information

Responsible Party: Phillip Brian Smith, Principal Investigator, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT02186652     History of Changes
Other Study ID Numbers: Pro00048765
Study First Received: July 3, 2014
Last Updated: June 21, 2017

Keywords provided by Phillip Brian Smith, Duke University Medical Center:
obese
children
adolescents
GERD
pharmacokinetic

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017