Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

NCT00300755

Last updated date
Study Location
Mobile, Alabama, 36604, United States
Contact
1-800-718-1021

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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
1-5 year
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Ability to undergo endoscopy with required biopsy

- Ages 1 through 5 years

- Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.

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


- History or presence of upper gastrointestinal anatomic or motor disorders


- Known current or active cow`s milk allergy


- Malignancy


- Other exclusions apply.

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  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,
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  67. Pietermaritzburg, KZN
  68. Durban,
  69. Overport,
  70. Pretoria,
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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
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Gastroesophageal RefluxStudy Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD) NCT00365300
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  10. Tampa, Florida
  11. Augusta, Georgia
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  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
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  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,
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  29. Lublin,
  30. Warszaw,
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ALL GENDERS
1 Month+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
Official Title  ICMJE A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)
Brief Summary To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux
Intervention  ICMJE Drug: pantoprazole sodium enteric-coated spheroid
pediatric spheroids taken daily x 8 weeks
Study Arms  ICMJE
  • Active Comparator: 1
    Arm 1- Low Dose pantoprazole
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid
  • Active Comparator: 2
    Arm 2- Medium Dose pantoprazole
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid
  • Active Comparator: 3
    Arm 3- High Dose pantoprazole
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid
Publications * Baker R, Tsou VM, Tung J, Baker SS, Li H, Wang W, Rath N, Maguire MK, Comer GM. Clinical results from a randomized, double-blind, dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis. Clin Pediatr (Phila). 2010 Sep;49(9):852-65. doi: 10.1177/0009922810369253. Epub 2010 Jun 3.

*   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 14, 2010)
60
Original Enrollment  ICMJE
 (submitted: March 7, 2006)
65
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to undergo endoscopy with required biopsy
  • Ages 1 through 5 years
  • Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.

Exclusion Criteria:

  • History or presence of upper gastrointestinal anatomic or motor disorders
  • Known current or active cow`s milk allergy
  • Malignancy
  • Other exclusions apply.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00300755
Other Study ID Numbers  ICMJE 3001B3-328
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
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