Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

Back to Search
Print
Bookmark Trial

NCT00259012

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Little Rock, Arkansas, 72205, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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]

Call Now

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
1-11 month
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Greater than 44 weeks beyond neonatal period but less than 12 months

- Presumptive diagnosis of GERD

- Weight greater than 2.5 kg but less than 15 kg

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


- History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal
fistula, GI malabsorption


- Clinically significant medical or surgical abnormalities

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Gastroesophageal RefluxIntravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants
NCT00744419
  1. Louisville, Kentucky
ALL GENDERS
28 Weeks+
years
MULTIPLE SITES
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,
ALL GENDERS
0+
years
MULTIPLE SITES
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
  43. Montreal, Quebec
ALL GENDERS
1 Year+
years
MULTIPLE SITES
Gastroesophageal RefluxStudy Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
NCT00365300
  1. Mobile, Alabama
  2. Phoenix, Arizona
  3. Little Rock, Arkansas
  4. Oakland, California
  5. Orange, California
  6. Washington, District of Columbia
  7. Miami, Florida
  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
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
Official Title  ICMJE A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
Brief Summary The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.
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 sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days
Study Arms  ICMJE
  • Active Comparator: Low dose
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid suspension
  • Active Comparator: High dose
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid suspension
Publications * Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000.

*   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 19, 2010)		67
Original Enrollment  ICMJE
 (submitted: November 23, 2005)		72
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Greater than 44 weeks beyond neonatal period but less than 12 months
  • Presumptive diagnosis of GERD
  • Weight greater than 2.5 kg but less than 15 kg

Exclusion Criteria:

  • History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
  • Clinically significant medical or surgical abnormalities
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Month to 11 Months   (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,   France,   Germany,   Italy,   Poland,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00259012
Other Study ID Numbers  ICMJE 3001B3-333, 3001B3-335
Has Data Monitoring Committee No
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 Nycomed
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Australia, [email protected]
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor France, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Poland, [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