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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Pantoprazole

Criteria

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.