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

Overview[ - collapse ][ - ]

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.
ConditionGastroesophageal Reflux
InterventionDrug: pantoprazole
PhasePhase 3
SponsorWyeth is now a wholly owned subsidiary of Pfizer
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov IdentifierNCT00868296
First ReceivedMarch 20, 2009
Last UpdatedApril 29, 2010
Last verifiedApril 2010

Tracking Information[ + expand ][ + ]

First Received DateMarch 20, 2009
Last Updated DateApril 29, 2010
Start DateMarch 2006
Estimated Primary Completion DateMarch 2008
Current 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.
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleOpen Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)
Official TitleA 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
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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionGastroesophageal Reflux
InterventionDrug: pantoprazole
Study Arm (s)
  • Active Comparator: Low dose
  • Active Comparator: High dose

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment58
Estimated Completion DateMarch 2008
Estimated Primary Completion DateMarch 2008
Eligibility 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.
GenderBoth
AgesN/A
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, South Africa, Switzerland

Administrative Information[ + expand ][ + ]

NCT Number NCT00868296
Other Study ID Numbers3001B3-335
Has Data Monitoring CommitteeNot Provided
Information Provided ByWyeth is now a wholly owned subsidiary of Pfizer
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of PfizerPrincipal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.comPrincipal Investigator: Trial Manager For Germany, medinfoDEU@wyeth.comPrincipal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.comPrincipal Investigator: Trial Manager For Poland, WPWZMED@wyeth.comPrincipal Investigator: Trial Manager For South Africa, ZAFinfo@wyeth.comPrincipal Investigator: Trial Manager For Australia, medinfo@wyeth.comPrincipal Investigator: Trial Manager For France, infomedfrance@wyeth.comPrincipal Investigator: Trial Manager For Italy, descresg@wyeth.comPrincipal Investigator: Trial Manager For Switzerland, med@wyeth.com
Verification DateApril 2010

Locations[ + expand ][ + ]

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