Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan

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NCT00141154

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Study Location
Pfizer Investigational Site
Funabashi-shi, Chiba, , Japan
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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

- Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower

- Patients who have had low back pain for at least two weeks

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


- Patients who have a previous history or complication of rheumatoid arthritis,
spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic
arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of
spinal cord or intervertebral disc, or any other disease which can cause systemic pain

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Pfizer Clinical Trials Contact Center

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NCT00141154
  1. Funabashi-shi, Chiba
  2. Funabashi, Chiba
  3. Matsudo-shi, Chiba
  4. Fukuoka-shi, Fukuoka
  5. Chitose, Hokkaido
  6. Sapporo-shi, Hokkaido
  7. Sapporo, Hokkaido
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  16. Kumagayashi, Saitama
  17. Minamisaitama-gun, Saitama
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  20. Adachi-Ku, Tokyo
  21. Bunkyou-ku, Tokyo
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  23. Itabashi-ku, Tokyo
  24. Koito-ku, Tokyo
  25. Meguro-Ku, Tokyo
  26. Nakano-ku, Tokyo
  27. Nerima-ku, Tokyo
  28. Ota-Ku, Tokyo
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  30. Setagaya-ku, Tokyo
  31. Shibuya-ku, Tokyo
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  33. Shinjyuku-ku, Tokyo
  34. Suginami-ku, Tokyo
  35. Sumida-ku, Tokyo
  36. Toyoshima-ku, Tokyo
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  10. Tempe, Arizona
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  14. Garden Grove, California
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  16. Los Gatos, California
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  20. Sacramento, California
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  45. Topeka, Kansas
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  47. Madisonville, Kentucky
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  97. Houston, Texas
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  8. Scottsdale, Arizona
  9. Tempe, Arizona
  10. Tempe, Arizona
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  13. Burbank, California
  14. Fresno, California
  15. Garden Grove, California
  16. La Jolla, California
  17. Los Gatos, California
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  21. Sacramento, California
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  24. Windomar, California
  25. Stamford, Connecticut
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  28. DeFuniak Springs, Florida
  29. DeLand, Florida
  30. Fort Lauderdale, Florida
  31. Jacksonville, Florida
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  33. Orlando, Florida
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  35. Pinellas Park, Florida
  36. South Miami, Florida
  37. St. Petersburg, Florida
  38. West Palm Beach, Florida
  39. Atlanta, Georgia
  40. Blue Ridge, Georgia
  41. Marietta, Georgia
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  43. Evansville, Indiana
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  45. Prairie Village, Kansas
  46. Topeka, Kansas
  47. Lexington, Kentucky
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  49. Monroe, Louisiana
  50. Baltimore, Maryland
  51. Worcester, Massachusetts
  52. Lansing, Michigan
  53. Biloxi, Mississippi
  54. Jackson, Mississippi
  55. St. Louis, Missouri
  56. Omaha, Nebraska
  57. Omaha, Nebraska
  58. Las Vagas, Nevada
  59. Las Vegas, Nevada
  60. Berlin, New Jersey
  61. Willingboro, New Jersey
  62. Albuquerque, New Mexico
  63. Manlius, New York
  64. New York, New York
  65. New York, New York
  66. Rochester, New York
  67. Rochester, New York
  68. Williamsville, New York
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  70. Lenoir, North Carolina
  71. Raleigh, North Carolina
  72. Winston-Salem, North Carolina
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  80. Altoona, Pennsylvania
  81. Bethlehem, Pennsylvania
  82. Bridgeville, Pennsylvania
  83. Duncansville, Pennsylvania
  84. Philadelphia, Pennsylvania
  85. Cranston, Rhode Island
  86. Warwick, Rhode Island
  87. Columbia, South Carolina
  88. Greer, South Carolina
  89. Rapid City, South Dakota
  90. Germantown, Tennessee
  91. Johnson City, Tennessee
  92. Austin, Texas
  93. Austin, Texas
  94. Beaumont, Texas
  95. Bryan, Texas
  96. Carroltown, Texas
  97. Houston, Texas
  98. Houston, Texas
  99. Houston, Texas
  100. Houston, Texas
  101. Nassau Bay, Texas
  102. San Antonio, Texas
  103. San Antonio, Texas
  104. Salt Lake City, Utah
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  106. Charlottesville, Virginia
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Advanced Information
Descriptive Information
Brief Title  ICMJE Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan
Official Title  ICMJE A Randomized, Multicenter, Active And Placebo Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Celecoxib (Ym177) 200 Bid Compared To Loxoprofen 60 Mg Tid In Patients With Low Back Pain
Brief Summary To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: Celecoxib
  • Drug: Placebo
  • Drug: Loxoprofen
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: May 27, 2011)		1234
Original Enrollment  ICMJE
 (submitted: August 30, 2005)		1206
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower
  • Patients who have had low back pain for at least two weeks

Exclusion Criteria:

  • Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141154
Other Study ID Numbers  ICMJE A3191174
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

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