Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease. |
|---|---|
| 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 | NCT00362609 |
| First Received | August 8, 2006 |
| Last Updated | April 22, 2010 |
| Last verified | April 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 8, 2006 |
|---|---|
| Last Updated Date | April 22, 2010 |
| Start Date | July 2006 |
| Estimated Primary Completion Date | December 2007 |
| Current Primary Outcome Measures | Variance of Oral Bioavailability [Time Frame: 1 day] [Designated as safety issue: No]Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was >1.2. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD |
|---|---|
| Official Title | A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD |
| Brief Summary | The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel 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 |
|---|---|
| Estimated Enrollment | 59 |
| Estimated Completion Date | December 2007 |
| Estimated Primary Completion Date | December 2007 |
| Eligibility Criteria | Inclusion Criteria: - Hospitalized patients - Presumed diagnosis of GERD - Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks Exclusion Criteria: - cardiovascular instability - clinically significant laboratory abnormalities - use of warfarin, carbamazepine, phenytoin, or rifampin |
| 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 | NCT00362609 |
|---|---|
| Other Study ID Numbers | 3001B3-331, 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 |
|---|---|
| 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 |