Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

Verified by: Wyeth is now a wholly owned subsidiary of Pfizer, April 2010
First Received: November 23, 2005 | Last Updated: April 19, 2010 | Phase: Phase 3 | Start Date: November 2005
Overall Status: Completed | Estimated Enrollment: 67
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The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months...

Brief Summary

Official Title: “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”

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

  • Drug: pantoprazole sodium enteric-coated spheroid suspension
    • pediatric suspension taken daily x 7 days

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Low dose
  • Active Comparator: High dose

Outcome Measures for this Clinical Trial

Primary Measures

  • Peak Concentration (Cmax)
    • Time Frame: 1 day
      Safety Issue?: No
  • Time to Peak Concentration (Tmax) Profile
    • Time Frame: 1 day
      Safety Issue?: No
  • Disposition Half-life
    • Time Frame: 1 day
      Safety Issue?: No
  • Area Under the Concentration-time Curve (AUC)
    • Time Frame: 1 day
      Safety Issue?: No
  • Apparent Oral Clearance (CL/F)
    • Time Frame: 1 day
      Safety Issue?: No
  • Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
    • Time Frame: 7 days
      Safety Issue?: No
  • Intragastric pH
    • Time Frame: 7 days
      Safety Issue?: No
  • Median Intragastric pH
    • Time Frame: 7 days
      Safety Issue?: No
  • Percentage of Time Intragastric pH Was >4
    • Time Frame: 7 days
      Safety Issue?: No
  • Mean Intraesophageal pH
    • Time Frame: 7 days
      Safety Issue?: No
  • Median Intraesophageal pH
    • Time Frame: 7 days
      Safety Issue?: No
  • Percentage of Time That Intraesophageal pH Was <4
    • Time Frame: 7 days
      Safety Issue?: No
  • Normalized Area of Gastric Hydrogen Ion Activity Over Time
    • Time Frame: 7 days
      Safety Issue?: No
  • Normalized Area of Esophageal Hydrogen Ion Activity Over Time
    • Time Frame: 7 days
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Greater than 44 weeks beyond neonatal period but less than 12 months
  • Presumptive diagnosis of GERD
  • Weight greater than 2.5 kg but less than 15 kg

Exclusion Criteria:

  • History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
  • Clinically significant medical or surgical abnormalities

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 11 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259012

Study ID Number: 3001B3-333, 3001B3-335

ClinicalTrials.gov Identifier: NCT00259012

Health Authority: United States: Food and Drug Administration

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