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Effect of Obesity on Proton Pump Inhibitors (LiverLabPPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04248335
Recruitment Status : Suspended (Suspended due to COVID-19; No suspension of IRB approval)
First Posted : January 30, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Valentina Shakhnovich, Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date  ICMJE January 27, 2020
First Posted Date  ICMJE January 30, 2020
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE January 27, 2020
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • plasma pharmacokinetics of pantoprazole [ Time Frame: 5 years ]
    plasma maximum peak concentration (Cmax)
  • plasma pharmacokinetics of pantoprazole [ Time Frame: 5 years ]
    area under the concentration time curve (AUC)
  • plasma pharmacokinetics of pantoprazole [ Time Frame: 5 years ]
    time to maximum peak concentration (tmax)
  • plasma pharmacokinetics of pantoprazole [ Time Frame: 5 years ]
    half-life (t 1/2)
  • plasma pharmacokinetics of pantoprazole [ Time Frame: 5 years ]
    volume of distribution (Vd)
  • plasma pharmacokinetics of pantoprazole [ Time Frame: 5 years ]
    clearance (CL)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
  • pharmacodynamics [ Time Frame: 5 years ]
    concentration of gastric acid using pH probe test
  • safety of pantoprazole: incidence of reported and gastrointestinal adverse events [ Time Frame: 5 years ]
    incidence of reported and gastrointestinal adverse events
  • pharmacokinetics of midazolam, if medication received to ease discomfort of pH probe study [ Time Frame: 5 years ]
    plasma concentrations of midazolam
  • urinary metabolites [ Time Frame: 5 years ]
    urine concentrations of pantoprazole and midazolam and their metabolites
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • pharmacodynamics [ Time Frame: 5 years ]
    concentration of gastric acid using pH probe test
  • safety of pantoprazole: incidence of reported and gastrointestinal adverse events [ Time Frame: 5 years ]
    incidence of reported and gastrointestinal adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Obesity on Proton Pump Inhibitors
Official Title  ICMJE Physiologic Determinants of PPI Disposition in Children
Brief Summary This longitudinal study tests the hypothesis that obesity affects drug pharmacology of acid suppression medications in children.
Detailed Description The purpose of this research study is to see how the body breaks down certain medicines. Many medicines are broken down in the liver. The liver is an organ in the belly. A person's age, size, genetics (DNA), and the health of their liver decide how quickly the body breaks down medicines and how much medication a person needs to take. Everybody's liver has some fat in it, but the amount of fat is different from person to person. The purpose of this study is to see if the amount of fat in the liver affects how quickly acid suppression medications start and stop working and get removed from the body.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pediatric Obesity
  • NAFLD
  • GERD
Intervention  ICMJE
  • Drug: Pantoprazole
    single-dose administration
  • Drug: Midazolam injection
    single-dose administration
Study Arms  ICMJE
  • Experimental: In Weight Management Program
    Evaluate the effect of liver fat on pharmacology of PPI's, and if applicable midazolam
    Interventions:
    • Drug: Pantoprazole
    • Drug: Midazolam injection
  • Experimental: Not in Weight Management Program
    Evaluate the effect of liver fat on drug metabolism of PPI's, and if applicable midazolam
    Interventions:
    • Drug: Pantoprazole
    • Drug: Midazolam injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 28, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ≥ 3 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04248335
Other Study ID Numbers  ICMJE STUDY00000201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified experimental data may be shared with institutional collaborators outside of CMH and if it is determined that biological samples obtained from study participants must be transferred to institutions outside of CMH for the purpose of confirmatory analyses, appropriate inter-institutional material transfer agreements will first be executed. As this is a pediatric study, minimal blood volumes are being collected and we do not anticipate that biological samples will be available to share with the outside community upon completion of the study, beyond those samples that may be required for confirmatory analyses.
Responsible Party Valentina Shakhnovich, Children's Mercy Hospital Kansas City
Study Sponsor  ICMJE Children's Mercy Hospital Kansas City
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Valentina Shakhnovich, MD Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP