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. |
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Condition | Gastroesophageal Reflux |
Intervention | Drug: pantoprazole |
Phase | Phase 3 |
Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
Responsible Party | 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 |
Tracking Information[ + expand ][ + ]
First Received Date | March 20, 2009 |
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Last Updated Date | April 29, 2010 |
Start Date | March 2006 |
Estimated Primary Completion Date | March 2008 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD) |
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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 |
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 Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Gastroesophageal Reflux |
Intervention | Drug: pantoprazole |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 58 |
Estimated Completion Date | March 2008 |
Estimated Primary Completion Date | March 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. |
Gender | Both |
Ages | N/A |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, South Africa, Switzerland |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00868296 |
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Other Study ID Numbers | 3001B3-335 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer |
Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
Collaborators | Not 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 Date | April 2010 |
Locations[ + expand ][ + ]
United States, Arizona | Phoenix, Arizona, United States, 85006 |
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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 |