Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants

NCT00744419 | Completed Phase 1 DMC

• 1 other identifier: UofL Panto 01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Keywords

GERD; pharmacokinetics; pantoprazole; neonates; infants

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

Secondary Outcomes (1)

• 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.

  From enrollment to 14 days after the last dose of study drug.

Study Arms (1)

3 age groups

EXPERIMENTAL

Assigned to the arm based on age.

Drug: pantoprazole

Interventions

pantoprazole DRUG

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 \[0.8 mg/kg(\< 44 wks PMA) or 1.6 mg/kg(44 wks to \< 1 yr)\]

Also known as: Protonix

3 age groups

Eligibility Criteria

• Age: 28 Weeks - 11 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Previous adverse reaction to proton pump inhibitor
• History of gastrointestinal anomalies, eosinophilic esophagitis, unrepaired tracheal esophageal fistula or liver disease
• Unstable cardiovascular, renal, hepatic, hematologic or endocrine disease
• History of acute life-threatening events due to GERD
• History of hepatitis B or hepatitis C
• Use of PPI's within 24 hours before study drug is administered
• Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome
• 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
• 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.
• Any disorder requiring chronic use of warfarin, oxcarbazepine, topiramate, carbamezapine, rifampin or phenytoin.
• Currently participating in another investigational drug trial or have participated in a study within the last 30 days.

Sponsors & Collaborators

• University of Louisville: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Louisville Research Foundation, Inc/KCPCRU

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Angela M Jeffries, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: May 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)