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Trial record 1 of 1 for:    NCT00744419
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Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants

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. Identifier: NCT00744419
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : December 3, 2015
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Janice E. Sullivan, University of Louisville

Tracking Information
First Submitted Date  ICMJE August 29, 2008
First Posted Date  ICMJE September 1, 2008
Last Update Posted Date December 3, 2015
Study Start Date  ICMJE May 2009
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2008)
The primary endpoint is to characterize the pharmacokinetics of intravenous pantoprazole after a single dose and multiple doses in neonates and infants less than one year of age with presumed GERD. [ Time Frame: 0, 0.5, 1, 2, 3, 6, 8 and 12 hours (Day 1) and 0, 2, 3 and 4 hours (Day 6) with a maximum of 6 samples per subject. (Each subject will be assigned to a specific PK group) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2008)
To describe the safety of pantoprazole in neonates and infants less than one year of age with presumed GERD. To compare the pantoprazole PK data obtained from this study population to data obtained from subjects greater than 1 year of age. [ Time Frame: From enrollment to 14 days after the last dose of study drug. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants
Official Title  ICMJE A Multicenter, Open-label, Single and Multiple Dose Pharmacokinetic Study of IV Pantoprazole in Preterm Infants and Infants 0-11 Months With a Clinical Diagnosis of Gastroesophageal Reflux Disease (GERD) or the Need for Acid Suppression
Brief Summary

The purpose of this study is to determine how the body uses and eliminates pantoprazole, a drug used to treat GERD. This is a pharmacokinetic (PK) study. PK is a measure of how much drug is in the blood and how long it takes to leave the body. It is hypothesized that younger infants will need a lower dose than older children to achieve the same PK measurement.

The results of this study will be used to determine the best dose of the drug to use in each age group. Pantoprazole is a drug used to decrease acid production. The use of pantoprazole has not been approved for use in children. Pantoprazole is approved for use of acid-related and stomach disorders in adults.

Detailed Description

Gastroesophageal reflux, regurgitation of gastric contents into the esophagus, and gastroesophageal reflux disease, displaying symptoms and complications from regurgitation, are both very common in infants. Daily reflux is present in up to 50% of infants younger than 3 months and in more than 66% at 4 months of age. GERD is primarily attributed to lower esophageal sphincter relaxation. Between 5-9% of infants less than one year of age have GERD and require acid suppression. Complications associated with GERD include failure to thrive, apnea, wheezing, recurrent aspiration, poor feeding, refusal to feed, irritability, and in more severe cases, acute life-threatening events.

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production through binding to the H+-K+-ATPase enzyme system at the surface of parietal cells in gastric epithelium. This causes a reduction in acid production regardless of the stimulus presented. Pantoprazole is used as therapy in GERD, erosive esophagitis, gastritis, gastric ulcerations, duodenal ulcerations and prophylaxis of stress gastritis in hospitalized patients. Pantoprazole is metabolized mainly by hepatic cytochrome P-450 CYP2C19 and is hypothesized to be metabolized at a higher rate in children as compared to adults. However, the metabolism of proton pump inhibitors is slower in infants < 10 weeks of age. Clinical studies are ongoing for the use of oral pantoprazole in infants and children.

Acid suppression is frequently required in hospitalized infants to treat GERD. In children who are critically ill, oral administration of acid suppressive agents is relatively contraindicated therefore an intravenous alternative such as intravenous pantoprazole is imperative. Intravenous pantoprazole has been well tolerated in pharmacokinetic studies in children ages 1 to 16 years. No systematic studies have been done to determine the pharmacokinetics of intravenous pantoprazole in infants less than 1 year of age therefore this study will meet an identified unmet need and address a knowledge deficit in this population. The aim of this study is to determine the pharmacokinetics of pantoprazole sodium for injection and evaluate the safety and tolerability of single and multiple intravenous doses in preterm neonates and infants 0-11 months of age using population pharmacokinetics. In addition, the genotyping for CYP2C19 and CYP3A4 polymorphisms will be performed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux
Intervention  ICMJE Drug: pantoprazole
Intravenous pantoprazole will be administered daiy for 6 (+/- 1 day). The first 6 subjects in each age group will receive low dose [0.4 mg/kg (< 44 wks PMA) or 0.8 mg/kg (44 wks to < 1 yr)] and the last 6 subjects in each age group will receive high dose [0.8 mg/kg(< 44 wks PMA) or 1.6 mg/kg(44 wks to < 1 yr)]
Other Name: Protonix
Study Arms  ICMJE Experimental: 3 age groups
Assigned to the arm based on age.
Intervention: Drug: pantoprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2013)
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2008)
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent and HIPAA documents by parent/legal guardian.
  2. Hospitalized premature neonates (Post menstrual age (PMA) 28 - < 34 weeks), neonates (PMA 34 to 44 weeks), and infants (PMA > 44 weeks to 11 months).
  3. Clinical indication for acid suppression or a presumptive diagnosis of GERD based on clinical symptoms and/or objective tests diagnostic of GERD.
  4. Body weight of at least 750 grams (based on blood volume required for study participation).

Exclusion Criteria:

  1. Previous adverse reaction to proton pump inhibitor
  2. History of gastrointestinal anomalies, eosinophilic esophagitis, unrepaired tracheal esophageal fistula or liver disease
  3. Unstable cardiovascular, renal, hepatic, hematologic or endocrine disease
  4. History of acute life-threatening events due to GERD
  5. History of hepatitis B or hepatitis C
  6. Use of PPI's within 24 hours before study drug is administered
  7. Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome
  8. Clinically significant laboratory values:

    • Aspartate aminotransferase (AST) or alanine aminotransferase (AST) >2 times the upper limit of normal (ULN) for age
    • Total bilirubin > 2 times ULN for age
    • Alkaline phosphatase > 2 times ULN for age

10.Use of histamine-2 receptor blockers (eg. Cimetidine, famotidine, ranitidine, or nizatidine) sucralfate, misoprostol, or prokinetic agents (eg. urecholine, erythromycin, or metoclopramide) and antacids or bismuth preparations within 24 hours before test article administration.

11.Any disorder requiring chronic use of warfarin, oxcarbazepine, topiramate, carbamezapine, rifampin or phenytoin.

12.Currently participating in another investigational drug trial or have participated in a study within the last 30 days.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 28 Weeks to 11 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
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 NCT00744419
Other Study ID Numbers  ICMJE UofL Panto 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janice E. Sullivan, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Angela M Jeffries, MD University of Louisville
PRS Account University of Louisville
Verification Date December 2015

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