Study Evaluating ERB-041 in Active Crohn's Disease

Back to Search
Print
Bookmark Trial

NCT00245947

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
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.
Crohn's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men and women, minimum 18 years of age with a diagnosis of Crohn's disease greater than 3 months,

- Eligible subjects must have adequate hematologic, renal, and hepatic function.

Other inclusions apply

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


- Use of the following medications within the specified time period before randomization
is prohibited:


Within 48 hours before randomization


- Nonsteroidal antiinflammatory drugs (NSAIDs) Within 2 weeks before randomization


- Herbal supplements (except for a daily multivitamin/mineral supplement not containing
herbal components).


Other exclusions applies

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

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

Crohn's DiseaseDemonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
NCT02096861
  1. Nashville, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Crohn's DiseaseSafety of Celecoxib in Patients With Crohn's Disease
NCT00177866
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Crohn's DiseaseTop-down Infliximab Study in Kids With Crohn's Disease
NCT02517684
  1. Brussels,
  2. Leuven,
  3. Helsinki,
  4. Rotterdam, Zuid-Holland
  5. Amsterdam,
  6. Amsterdam,
  7. Breda,
  8. Enschede,
  9. Leiden,
  10. Nijmegen,
  11. Rotterdam,
  12. Utrecht,
  13. Zwolle,
ALL GENDERS
3 Years+
years
MULTIPLE SITES
Crohn's DiseaseB0151005 Open-Label Extension Study
NCT01345318
  1. Scottsdale, Arizona
  2. Scottsdale, Arizona
  3. Tucson, Arizona
  4. Tuscon, Arizona
  5. Lakewood, Colorado
  6. Littleton, Colorado
  7. Wheat Ridge, Colorado
  8. Wheatridge, Colorado
  9. Hamden, Connecticut
  10. Clearwater, Florida
  11. Clearwater, Florida
  12. Crystal River, Florida
  13. Inverness, Florida
  14. Inverness, Florida
  15. Sanford, Florida
  16. Decatur, Georgia
  17. Decatur, Georgia
  18. Marietta, Georgia
  19. Arlington Heights, Illinois
  20. Chicago, Illinois
  21. Evanston, Illinois
  22. Lexington, Kentucky
  23. Louisville, Kentucky
  24. Louisville, Kentucky
  25. Annapolis, Maryland
  26. Annapolis, Maryland
  27. Grand Rapids, Michigan
  28. Wyoming, Michigan
  29. Wyoming, Michigan
  30. Wyoming, Michigan
  31. Ypsilanti, Michigan
  32. New York, New York
  33. New York, New York
  34. New York, New York
  35. New York, New York
  36. New York, New York
  37. New York, New York
  38. New York, New York
  39. Oklahoma City, Oklahoma
  40. Oklahoma City, Oklahoma
  41. Oklahoma, Oklahoma
  42. Tulsa, Oklahoma
  43. Tulsa, Oklahoma
  44. Pittsburgh, Pennsylvania
  45. Pittsburgh, Pennsylvania
  46. Germantown, Tennessee
  47. Nashville, Tennessee
  48. Nashville, Tennessee
  49. Nashville, Tennessee
  50. Nashville, Tennessee
  51. Austin, Texas
  52. Austin, Texas
  53. Houston, Texas
  54. Houston, Texas
  55. Houston, Texas
  56. Houston, Texas
  57. Southlake, Texas
  58. Tyler, Texas
  59. Tyler, Texas
  60. Salt Lake City, Utah
  61. Richmond, Virginia
  62. Richmond, Virginia
  63. Concord, New South Wales
  64. Brisbane, Queensland
  65. South Brisbane, Queensland
  66. Box Hill, Victoria
  67. Clayton, Victoria
  68. Fitzroy, Victoria
  69. Bruxelles,
  70. Bruxelles,
  71. Leuven,
  72. Roeselare,
  73. Curitiba, PR
  74. Curitiba, PR
  75. Curitiba, PR
  76. Rio de Janeiro, RJ
  77. Rio de Janeiro, RJ
  78. São Paulo, SP
  79. Calgary, Alberta
  80. London, Ontario
  81. Toronto, Ontario
  82. Montreal, Quebec
  83. Hradec Kralove,
  84. Olomouc,
  85. Praha 10,
  86. Praha 4,
  87. Usti nad Labem,
  88. Aarhus C,
  89. Herlev,
  90. Hilleroed,
  91. Hvidovre,
  92. Koebenhavn NV,
  93. Koebenhavn,
  94. Koege,
  95. Paris, Cedex 12
  96. Lille Cedex,
  97. Hannover, Niedersachsen
  98. Hamburg,
  99. Kiel,
  100. Minden,
  101. Budapest,
  102. Debrecen,
  103. Szeged,
  104. Szekszard,
  105. Dublin,
  106. Dublin,
  107. Dublin,
  108. Dublin,
  109. Galway,
  110. Beith Vagan, Jerusalem
  111. Haifa,
  112. Jerusalem,
  113. Kfar Saba,
  114. Petah Tikva,
  115. Tel Aviv,
  116. Rozzano, Milano
  117. Padova,
  118. Roma,
  119. Rome,
  120. Milford, Auckland
  121. Hamilton,
  122. Zuerich,
  123. Cambridge,
  124. Glasgow,
  125. London,
  126. London,
  127. London,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating ERB-041 in Active Crohn's Disease
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's Disease
Brief Summary Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with inflammation associated with active Crohn's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE Drug: ERB-041
Study Arms  ICMJE Not Provided
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: September 9, 2009)		22
Original Enrollment  ICMJE
 (submitted: October 26, 2005)		48
Actual Study Completion Date  ICMJE April 2005
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women, minimum 18 years of age with a diagnosis of Crohn's disease greater than 3 months,
  • Eligible subjects must have adequate hematologic, renal, and hepatic function.

Other inclusions apply

Exclusion Criteria:

  • Use of the following medications within the specified time period before randomization is prohibited:

Within 48 hours before randomization

  • Nonsteroidal antiinflammatory drugs (NSAIDs) Within 2 weeks before randomization
  • Herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components).

Other exclusions applies

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00245947
Other Study ID Numbers  ICMJE 3142A3-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
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
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2009

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