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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: pantoprazole

• Registration Number: NCT00868296
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-24
• Disposition First Submitted: 2009-03-24
• Results First Submitted: 2009-11-30
• Results First Submitted QC: 2009-11-30
• Disposition First Submitted QC: 2009-11-30
• Results First Posted: 2010-01-07
• Disposition First Posted: 2010-01-07
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-29
• Last Update Posted: 2010-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low dose	pantoprazole	-
High dose	pantoprazole	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period	6 weeks	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	6 weeks	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.