Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

NCT00141193

Last updated date
Study Location
Pfizer Investigational Site
San Diego, California, 92123, 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.
Colorectal Adenoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- The subject has had a documented colonoscopy to the cecum performed by a study-related physician with adequate preparation resulting in diagnosis and clearance of an adenomatous polyp(s) within 4 months prior to randomization.

- The subject is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors excluding aspirin at cardioprotective doses for the duration of the study.

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


- The subject has a history of Familial Adenomatous Polyposis or Hereditary
Non-Polyposis Colorectal Cancer.


- The subject has a history of inflammatory bowel disease.

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Colorectal AdenomaPrevention of Colorectal Sporadic Adenomatous Polyps (PRESAP) NCT00141193
  1. San Diego, California
  2. San Kiego, California
  3. North Chicago, Illinois
  4. Oak Park, Illinois
  5. Baltimore, Maryland
  6. Baltimore, Maryland
  7. Philadelphia, Pennsylvania
  8. Philadelphia, Pennsylvania
  9. Houston, Texas
  10. Richmond, Virginia
  11. Townsville, Queensland
  12. Geelong, Victoria
  13. Brussels,
  14. Bruxelles,
  15. Bruxelles,
  16. Gent,
  17. Porto Alegre, RS
  18. São Paulo, SP
  19. Edmonton, Alberta
  20. Abbotsford, British Columbia
  21. Vancouver, British Columbia
  22. Vancouver, British Columbia
  23. Kingston, Ontario
  24. London, Ontario
  25. St. John's,
  26. Santiago, RM
  27. Beijing,
  28. Beijing,
  29. Brno,
  30. Hradec Kralove,
  31. Liberec,
  32. Prague 10,
  33. Prague 6,
  34. Prague,
  35. Prague,
  36. Arhus C,
  37. Oulu,
  38. Bobigny,
  39. Lyon,
  40. Marseille Cedex 09,
  41. Paris Cedex 14,
  42. Berlin,
  43. Erlangen,
  44. Freising,
  45. Hamburg,
  46. Kuenzing,
  47. Ludwigshafen,
  48. Marburg,
  49. Muenchen,
  50. Munchen,
  51. Ulm,
  52. Hong Kong,
  53. New Territories,
  54. Gyor,
  55. Szekszárd,
  56. Wilton, Cork
  57. Dublin,
  58. Beer-Sheeva,
  59. Hadera,
  60. Haifa,
  61. Hashomer,
  62. Holon,
  63. Jerusalem,
  64. Petah-Tikva,
  65. Tel-Aviv,
  66. San Giovanni Rotondo, Italy/Foggia/Italy
  67. Brescia,
  68. Milano,
  69. Roma,
  70. Roma,
  71. Siena,
  72. Maastricht,
  73. Skien,
  74. Lima,
  75. Warsaw,
  76. Lisboa,
  77. Moscow,
  78. Moscow,
  79. Moscow,
  80. Moscow,
  81. Moscow,
  82. Moscow,
  83. Singapore,
  84. Singapore,
  85. Bratislava,
  86. Bratislava,
  87. Johannesburg, Gauteng
  88. Johannesburg, Gauteng
  89. Johannesburg, Gauteng
  90. Cape Town, Western
  91. Oviedo, Asturias
  92. San Sebastian, Guipuzcoa
  93. Palma de Mallorca, Islas Baleares
  94. Barcelona,
  95. Sevilla,
  96. Stockholm,
  97. Uppsala,
  98. Geneve 14,
  99. Kaohsiung,
  100. Newport, Gwent
  101. Harrow, Middlesex
  102. Glasgow,
  103. Oxford,
  104. Montevideo,
  105. Montevideo,
  106. Montevideo,
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Official Title  ICMJE Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Brief Summary This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Adenoma
Intervention  ICMJE Drug: Celecoxib
Study Arms  ICMJE Placebo Comparator: A
Intervention: Drug: Celecoxib
Publications *

*   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: December 20, 2007)
1561
Original Enrollment  ICMJE
 (submitted: August 30, 2005)
1500
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject has had a documented colonoscopy to the cecum performed by a study-related physician with adequate preparation resulting in diagnosis and clearance of an adenomatous polyp(s) within 4 months prior to randomization.
  • The subject is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors excluding aspirin at cardioprotective doses for the duration of the study.

Exclusion Criteria:

  • The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
  • The subject has a history of inflammatory bowel disease.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Netherlands,   Norway,   Peru,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States,   Uruguay
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141193
Other Study ID Numbers  ICMJE EQ4-00-02-018
A3191107
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2008

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