A MULTICENTER, RANDOMIZED, OPEN LABEL, SINGLE AND MULTIPLE DOSE STUDY OF THE PHARMACOKINETICS AND PHARMACODYNAMICS OF 2 DOSE LEVELS OF PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED 1 THROUGH 11 MONTHS WITH PRESUMED GERD.

Phase 1

• Conditions: INFANTS AGED 1 THROUGH 11 MONTHS WITH PRESUMED GERD

• Registration Number: EUCTR2006-001132-45-FR
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-24
• Study Completion: 2008-01-29
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1) Male or female term or post term infants beyond the neonatal period > 44 weeks but < 12 months of age, or preterm infants with a corrected age of at least 44 weeks but < 12 months at the time the informed consent is signed.
2) Have a presumptive diagnosis of GERD requiring pharmacologic treatment. The method used for the diagnosis of presumptive GERD will be recorded.
3) Weight must be >=2.5 kg and <=15 kg.
4) The patients may be hospitalized patients or outpatients at the time of study entry.
5) Patients must be able to swallow the suspension.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)History of any of the following gastrointestinal disorders:
a)Unrepaired tracheal esophageal fistula.b)Gastrointestinal malabsorption.
2)Clinically significant medical or surgical abnormalities during the prestudy screening period physical examination, electrocardiogram (ECG), or laboratory test, as assessed by the investigator. This includes:
a)Unstable cardiovascular, renal, hepatic, hematologic, or endocrine disease except with prior approval of Wyeth medical monitor.
b)Active childhood infectious diseases (eg, measles, mumps, or chickenpox).
c)Known coagulation disorders (eg, hemophilia).
3)Known history of human immunodeficiency virus (HIV) or clinical manifestations of acquired immune deficiency syndrome (AIDS) or other immunodeficiency disorder.
4)Presence of terminal malignancy or any malignancy requiring treatment with radiation or chemotherapy within the past 6 months or if such treatment is planned within 30 days after the start of test article.
5)Clinically significant laboratory abnormality of the following laboratory tests: a)Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>=2 times upper limit of normal (ULN). b)Total bilirubin >=2mg/dL.c)Alkaline phosphatase>= 2 times ULN (age corrected).
6)Known positive serologic test results for hepatitis B virus antigen (HBsAg) or hepatitis C virus (HCV) (antibody or RNA).
7)Known hypersensitivity to proton pump inhibitors (PPIs), including pantoprazole.
8)PK Portion: History of treatment with PPIs within 24 hours before test article administration.
PD or PK/PD Portion: Patients undergoing PD assessments may not have had PPIs for 7 days before baseline pH-metry.
9)PK Portion: Use of histamine 2 receptor blockers (H2RAs) within 24 hours before test article administration.
PD or PK/PD Note: Patients undergoing PD assessments may not have had H2RAs for 3 days before baseline pH-metry.
10) Use of antacids is prohibited 2 hours before PK laboratory blood draws and/or 2 hours before and during 24 hour pH-metry procedures.
11) Sucralfate, bismuth preparations, misoprostil or prokinetic agents should be discontinued 24 hours before test article administration.
12) Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin.
13)Participation in any other investigational drug trial or experimental trial within 30 days before administration of test article without approval from the Wyeth medical monitor.
14)History of recent acute-life threatening events due to manifestations of GERD.
15) Patient or PARENT felt to be unable to comply with study procedures in the investigator’s opinion.
16)Continuous enteral feeding or any feeding more frequently than every 3 hours is prohibited in patients participating in PD or PK/PD portion of the study.
17)Use of special diets or herbal or alternative medication that might affect the metabolism of test article without prior approval of the Wyeth medical monitor.
18)Known or suspected infectious eophagitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the PK profile of single and repeated doses of pantoprazole and the PD profile at baseline and at steady state after multiple doses of pantoprazole in infants aged 1 through 11 months with presumed GERD. ;Secondary Objective: To assess the safety and tolerability of pantoprazole in infants aged 1 through 11 months with presumed GERD.;Primary end point(s): Pharmacokinetics<br>Single dose PK assessments will be performed after the first dose of test article. Multiple dose PK will be assessed on day 7 ± 2 of test article administration after at least 5 consecutive (but not more than 10) doses of test article. <br><br>Pharmacodynamics<br>The PD assessments will occur at baseline and at steady state (after at least five consecutive but not more than 10 doses) by measurement of intragasric and intraesophageal pH for up to 24hours. pH-metry will be used to define the PD of Pantoprazole in this patient population.