Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

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NCT00362609

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Study Location
Phoenix, Arizona, 85006, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastroesophageal Reflux
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-28
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- cardiovascular instability


- clinically significant laboratory abnormalities


- use of warfarin, carbamazepine, phenytoin, or rifampin

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Gastroesophageal RefluxStudy Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
NCT00362609
  1. Phoenix, Arizona
  2. Loma Linda, California
  3. Oakland, California
  4. Orange, California
  5. Sacramento, California
  6. San Diego, California
  7. New Haven, Connecticut
  8. Washington, District of Columbia
  9. Gainesville, Florida
  10. Miami, Florida
  11. Sunrise, Florida
  12. Atlanta, Georgia
  13. Honolulu, Hawaii
  14. Boise, Idaho
  15. Chicago, Illinois
  16. Park Ridge, Illinois
  17. Lexington, Kentucky
  18. Louisville, Kentucky
  19. New Orleans, Louisiana
  20. Baltimore, Maryland
  21. Boston, Massachusetts
  22. Flint, Michigan
  23. Omaha, Nebraska
  24. Camden, New Jersey
  25. New Brunswick, New Jersey
  26. Newark, New Jersey
  27. Albany, New York
  28. Bronx, New York
  29. Brooklyn, New York
  30. New York, New York
  31. Valhalla, New York
  32. Durham, North Carolina
  33. Winston-Salem, North Carolina
  34. Oklahoma City, Oklahoma
  35. Portland, Oregon
  36. Danville, Pennsylvania
  37. Memphis, Tennessee
  38. Nashville, Tennessee
  39. Dallas, Texas
  40. San Antonio, Texas
  41. Salt Lake City, Utah
  42. Burlington, Vermont
  43. Richmond, Virginia
  44. Morgantown, West Virginia
  45. Milwaukee, Wisconsin
  46. Brisbane,
  47. Edegem,
  48. Leuven,
  49. Vancouver, British Columbia
  50. Ottawa, Ontario
  51. Toronto, Ontario
  52. Montreal, Quebec
  53. Sainte-Foy, Quebec
  54. Paris Cedex,
  55. Paris Cedex,
  56. Bochum,
  57. Osnabrueck,
  58. Potsdam,
  59. Brescia,
  60. Napoli,
  61. Roma,
  62. Rotterdam,
  63. Bydgoszcz,
  64. Krakow,
  65. Lublin,
  66. Panorama, CPT
  67. Pietermaritzburg, KZN
  68. Durban,
  69. Overport,
  70. Pretoria,
  71. Zurich,
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Gastroesophageal RefluxStudy Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
NCT00300755
  1. Mobile, Alabama
  2. Phoenix, Arizona
  3. Oakland, California
  4. Orange, California
  5. Sacramento, California
  6. San Diego, California
  7. Wilmington, Delaware
  8. Washington, District of Columbia
  9. Gainesville, Florida
  10. Jacksonville, Florida
  11. Miami, Florida
  12. Orlando, Florida
  13. Pensacola, Florida
  14. Peoria, Illinois
  15. Lexington, Kentucky
  16. Louisville, Kentucky
  17. Boston, Massachusetts
  18. Boston, Massachusetts
  19. Flint, Michigan
  20. Southfield, Michigan
  21. Jackson, Mississippi
  22. Omaha, Nebraska
  23. Las Vegas, Nevada
  24. Egg Harbor Township, New Jersey
  25. Morristown, New Jersey
  26. Buffalo, New York
  27. New York, New York
  28. Oklahoma City, Oklahoma
  29. Danville, Pennsylvania
  30. Philadelphia, Pennsylvania
  31. Houston, Texas
  32. Temple, Texas
  33. Norfolk, Virginia
  34. Charleston, West Virginia
  35. Huntington, West Virginia
  36. Milwaukee, Wisconsin
  37. Edmonton, Alberta
  38. St. John's, Newfoundland and Labrador
  39. Hamilton, Ontario
  40. London, Ontario
  41. Ottawa, Ontario
  42. Montreal, Quebec
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  1. Mobile, Alabama
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  6. Washington, District of Columbia
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  8. Orlando, Florida
  9. Pensacola, Florida
  10. Tampa, Florida
  11. Augusta, Georgia
  12. Peoria, Illinois
  13. Bardstown, Kentucky
  14. Louisville, Kentucky
  15. Boston, Massachusetts
  16. Flint, Michigan
  17. Jackson, Mississippi
  18. Omaha, Nebraska
  19. Las Vegas, Nevada
  20. Camden, New Jersey
  21. Mays Landing, New Jersey
  22. Morristown, New Jersey
  23. Brooklyn, New York
  24. Buffalo, New York
  25. Valhalla, New York
  26. Durham, North Carolina
  27. Cincinnati, Ohio
  28. Oklahoma City, Oklahoma
  29. Bethlehem, Pennsylvania
  30. Memphis, Tennessee
  31. Temple, Texas
  32. Salt Lake City, Utah
  33. Burlington, Vermont
  34. Norfolk, Virginia
  35. Richmond, Virginia
  36. Huntington, West Virginia
  37. Morgantown, West Virginia
  38. Madison, Wisconsin
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Gastroesophageal RefluxStudy Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
NCT00259012
  1. Little Rock, Arkansas
  2. Loma Linda, California
  3. San Diego, California
  4. Washington, District of Columbia
  5. Miami, Florida
  6. Pensacola, Florida
  7. Chicago, Illinois
  8. Park Ridge, Illinois
  9. Louisville, Kentucky
  10. Shreveport, Louisiana
  11. Jackson, Mississippi
  12. Kansas City, Missouri
  13. New York, New York
  14. Durham, North Carolina
  15. Cleveland, Ohio
  16. Temple, Texas
  17. Brisbane,
  18. Antwerpen,
  19. Brussels,
  20. Gent,
  21. Paris,
  22. Aachen,
  23. Osnabruck,
  24. Brescia,
  25. Naples,
  26. Roma,
  27. Krakow,
  28. Lodz,
  29. Lublin,
  30. Warszaw,
  31. Zurich,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux
Intervention  ICMJE Drug: pantoprazole
Study Arms  ICMJE
  • Active Comparator: Low dose
    Intervention: Drug: pantoprazole
  • Active Comparator: High dose
    Intervention: Drug: pantoprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2010)		59
Original Enrollment  ICMJE
 (submitted: August 8, 2006)		44
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE up to 28 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Poland,   South Africa,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00362609
Other Study ID Numbers  ICMJE 3001B3-331, 3001B3-335
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
Principal Investigator:Trial ManagerFor Poland, [email protected]
Principal Investigator:Trial ManagerFor South Africa, [email protected]
Principal Investigator:Trial ManagerFor Australia, [email protected]
Principal Investigator:Trial ManagerFor France, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Switzerland, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP