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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00868296
First received: March 20, 2009
Last updated: April 29, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux
Drug: pantoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Growth Parameters Z-scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 58
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low dose Drug: pantoprazole
Active Comparator: High dose Drug: pantoprazole

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868296

  Show 71 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For Germany, medinfoDEU@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@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 Australia, medinfo@wyeth.com
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
Principal Investigator: Trial Manager For Italy, descresg@wyeth.com
Principal Investigator: Trial Manager For Switzerland, med@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00868296     History of Changes
Other Study ID Numbers: 3001B3-335
Study First Received: March 20, 2009
Results First Received: November 30, 2009
Last Updated: April 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Safety

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014