Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)

A Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD

The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux
• Intervention / Treatment: Drug: pantoprazole

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
• Belgium
  • Edegem, Belgium, 2650
  • Leuven, Belgium, 3000
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
    • Toronto, Ontario, Canada, M5G 1X8
  • Quebec
    • Montreal, Quebec, Canada, H3H 1P3
    • Sainte-Foy, Quebec, Canada, G1V 4G2
• France
  • Paris Cedex, France, 75674
  • Paris Cedex, France, 75935
• Germany
  • Bochum, Germany, 44797
  • Osnabrueck, Germany, 49074
  • Potsdam, Germany, 14467
• Italy
  • Brescia, Italy, 25123
  • Napoli, Italy, 80121
  • Roma, Italy, 00161
• Netherlands
  • Rotterdam, Netherlands, 3015 GJ
• Poland
  • Bydgoszcz, Poland, 85-165
  • Krakow, Poland, 33-663
  • Lublin, Poland, 20-093
• South Africa
  • Durban, South Africa, 3630
  • Overport, South Africa, 4067
  • Pretoria, South Africa, 0083
  • CPT
    • Panorama, CPT, South Africa, 7500
  • KZN
    • Pietermaritzburg, KZN, South Africa, 3235
• Switzerland
  • Zurich, Switzerland, 8032
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
  • California
    • Loma Linda, California, United States, 92354
    • Oakland, California, United States, 94609-1809
    • Orange, California, United States, 92868
    • Sacramento, California, United States, 95817
    • San Diego, California, United States, 92103
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8064
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
  • Florida
    • Gainesville, Florida, United States, 32610-0296
    • Miami, Florida, United States, 33101
    • Sunrise, Florida, United States, 33323
  • Georgia
    • Atlanta, Georgia, United States, 30322
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
  • Idaho
    • Boise, Idaho, United States, 83704
  • Illinois
    • Chicago, Illinois, United States, 60614
    • Park Ridge, Illinois, United States, 60068
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0284
    • Louisville, Kentucky, United States, 40202
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
  • Maryland
    • Baltimore, Maryland, United States, 21201
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
  • Michigan
    • Flint, Michigan, United States, 48503
  • Nebraska
    • Omaha, Nebraska, United States, 68105
  • New Jersey
    • Camden, New Jersey, United States, 08103
    • New Brunswick, New Jersey, United States, 08901
    • Newark, New Jersey, United States, 07103
  • New York
    • Albany, New York, United States, 12208
    • Bronx, New York, United States, 10467
    • Brooklyn, New York, United States, 11219
    • New York, New York, United States, 10032
    • Valhalla, New York, United States, 10595-1689
  • North Carolina
    • Durham, North Carolina, United States, 27710
    • Winston-Salem, North Carolina, United States, 27157
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
  • Oregon
    • Portland, Oregon, United States, 97239-3042
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-1320
  • Tennessee
    • Memphis, Tennessee, United States, 38163
    • Nashville, Tennessee, United States, 37232-9550
  • Texas
    • Dallas, Texas, United States, 75390-9063
    • San Antonio, Texas, United States, 78229
  • Utah
    • Salt Lake City, Utah, United States, 84113
  • Vermont
    • Burlington, Vermont, United States, 05401
  • Virginia
    • Richmond, Virginia, United States, 23298
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Successful completion of the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) Study.

Exclusion Criteria:

• Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High dose	Drug: pantoprazole
Active Comparator: Low dose	Drug: pantoprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period	Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive.	6 weeks
Growth Parameters Z-scores	Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.	6 weeks

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Trial Manager, For Australia, medinfo@wyeth.com; Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com; Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com; Principal Investigator: Trial Manager, For Switzerland, med@wyeth.com

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: March 20, 2009
• First Submitted That Met QC Criteria: March 23, 2009
• First Posted (Estimate): March 24, 2009

Study Record Updates

• Last Update Posted (Estimate): May 4, 2010
• Last Update Submitted That Met QC Criteria: April 29, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Safety
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: 3001B3-335