Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

NCT00649610

Last updated date
Study Location
Pfizer Investigational Site
Bs. As., , , Argentina
Contact
1-800-718-1021

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.
Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm

- Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain

- History of at least 1 reported episode of acute low back pain in the last 5 years

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


- History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other
diseases known to cause pain


- Moderate to severe scoliosis


- Back pain due to major trauma or visceral disorder


- Unwilling to refrain from commencing concomitant physiotherapy


- Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or
bleeding within 30 days prior to the first dose of study medication


- Any known laboratory abnormality, which in the opinion of the investigator, would
contraindicate study participation


- Subject was pregnant or lactating woman , or was a woman of childbearing potential not
using an acceptable method of contraception

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]

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.

Based on your search, you may also be interested in

Low Back PainComparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan 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
  8. Katougun, Hyogo
  9. Kobe, Hyogo
  10. Nishinomiya, Hyogo
  11. Sagamihara-shi, Kanagawa
  12. Yokohama-shi, Kanagawa
  13. Yokohama, Kanagawa
  14. Hatogaya-shi, Saitama
  15. Kumagaya-shi, Saitama
  16. Kumagayashi, Saitama
  17. Minamisaitama-gun, Saitama
  18. Saitama-shi, Saitama
  19. Tokorozawa, Saitama
  20. Adachi-Ku, Tokyo
  21. Bunkyou-ku, Tokyo
  22. Edogawa-ku, Tokyo
  23. Itabashi-ku, Tokyo
  24. Koito-ku, Tokyo
  25. Meguro-Ku, Tokyo
  26. Nakano-ku, Tokyo
  27. Nerima-ku, Tokyo
  28. Ota-Ku, Tokyo
  29. Ota-Ku, Tokyo
  30. Setagaya-ku, Tokyo
  31. Shibuya-ku, Tokyo
  32. Shinagawa-ku, Tokyo
  33. Shinjyuku-ku, Tokyo
  34. Suginami-ku, Tokyo
  35. Sumida-ku, Tokyo
  36. Toyoshima-ku, Tokyo
  37. Chiba,
  38. Fukuoka,
  39. Fukuoka,
  40. Tokyo,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Low Back PainLong Term Safety Study of Tanezumab in Chronic Low Back Pain NCT00924664
  1. Anniston, Alabama
  2. Hueytown, Alabama
  3. Huntsville, Alabama
  4. Mobile, Alabama
  5. Chandler, Arizona
  6. Peoria, Arizona
  7. Phoenix, Arizona
  8. Scottsdale, Arizona
  9. Tempe, Arizona
  10. Tempe, Arizona
  11. Little Rock, Arkansas
  12. Burbank, California
  13. Fresno, California
  14. Garden Grove, California
  15. La Jolla, California
  16. Los Gatos, California
  17. Oceanside, California
  18. Rancho Mirage, California
  19. Roseville, California
  20. Sacramento, California
  21. San Diego, California
  22. Upland, California
  23. Windomar, California
  24. Boulder, Colorado
  25. Colorado Springs, Colorado
  26. Stamford, Connecticut
  27. Trumbull, Connecticut
  28. Chiefland, Florida
  29. DeFuniak Springs, Florida
  30. DeLand, Florida
  31. Jacksonville, Florida
  32. Naples, Florida
  33. Orlando, Florida
  34. Pembroke Pines, Florida
  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
  42. Boise, Idaho
  43. Evansville, Indiana
  44. Prairie Village, Kansas
  45. Topeka, Kansas
  46. Lexington, Kentucky
  47. Madisonville, Kentucky
  48. Monroe, Louisiana
  49. Baltimore, Maryland
  50. Worcester, Massachusetts
  51. Biloxi, Mississippi
  52. Jackson, Mississippi
  53. Springfield, Missouri
  54. St. Louis, Missouri
  55. St. Louis, Missouri
  56. Omaha, Nebraska
  57. Omaha, Nebraska
  58. Las Vegas,, 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
  69. Greensboro, North Carolina
  70. Lenoir, North Carolina
  71. Raleigh, North Carolina
  72. Winston-Salem, North Carolina
  73. Cleveland, Ohio
  74. Oklahoma City, Oklahoma
  75. Oklahoma City, Oklahoma
  76. Medford, Oregon
  77. Portland, Oregon
  78. Altoona, Pennsylvania
  79. Bridgeville, Pennsylvania
  80. Duncansville, Pennsylvania
  81. Philadelphia, Pennsylvania
  82. Cranston, Rhode Island
  83. Warwick, Rhode Island
  84. Columbia, South Carolina
  85. Greer, South Carolina
  86. Rapid City, South Dakota
  87. Germantown, Tennessee
  88. Johnson City, Tennessee
  89. Austin, Texas
  90. Beaumont, Texas
  91. Beaumont, Texas
  92. Bryan, Texas
  93. Carroltown, Texas
  94. Dallas, Texas
  95. Houston, Texas
  96. Houston, Texas
  97. Houston, Texas
  98. Nassau Bay, Texas
  99. San Antonio, Texas
  100. Salt Lake City, Utah
  101. Salt Lake City, Utah
  102. Charlottesville, Virginia
  103. Norfolk, Virginia
  104. Richmond, Virginia
  105. Virginia Beach, Virginia
  106. Bellevue, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Low Back PainRandomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain NCT00649610
  1. Bs. As.,
  2. Buenos Aires,
  3. Goiania, Goias
  4. Curitiba, Parana
  5. Curitiba, PR
  6. Petropolis, Rio de Janeiro
  7. Sao Paulo, SP
  8. Sao Paulo, SP
  9. Sao Paulo, SP
  10. Sao Paulo,
  11. Santiago,
  12. Bogota, D.c.
  13. Bogota D.c,
  14. Cali-valle,
  15. Cartago City, Cartago
  16. Hatillo, San Jose
  17. Quito, Pichincha
  18. Toluca, Edo. de Mexico
  19. Zapopan, Jalisco
  20. Zapopan, Jalisco
  21. Puebla,
  22. Puebla,
  23. Puebla,
  24. Lima,
  25. Lima,
  26. Caracas, DF
  27. Caracas, DF
  28. Caracas, DF
  29. Caracas,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Low Back PainA Study of Tanezumab in Adults With Chronic Low Back Pain NCT00876187
  1. Anniston, Alabama
  2. Hueytown, Alabama
  3. Mobile, Alabama
  4. Chandler, Arizona
  5. Peoria, Arizona
  6. Phoenix, Arizona
  7. Phoenix, Arizona
  8. Scottsdale, Arizona
  9. Tempe, Arizona
  10. Tempe, Arizona
  11. Tucson, Arizona
  12. Little Rock, Arkansas
  13. Burbank, California
  14. Fresno, California
  15. Garden Grove, California
  16. La Jolla, California
  17. Los Gatos, California
  18. Oceanside, California
  19. Rancho Mirage, California
  20. Roseville, California
  21. Sacramento, California
  22. San Diego, California
  23. Upland, California
  24. Windomar, California
  25. Stamford, Connecticut
  26. Trumbull, Connecticut
  27. Chiefland, Florida
  28. DeFuniak Springs, Florida
  29. DeLand, Florida
  30. Fort Lauderdale, Florida
  31. Jacksonville, Florida
  32. Naples, Florida
  33. Orlando, Florida
  34. Pembroke Pines, Florida
  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
  42. Boise, Idaho
  43. Evansville, Indiana
  44. Overland Park, Kansas
  45. Prairie Village, Kansas
  46. Topeka, Kansas
  47. Lexington, Kentucky
  48. Madisonville, Kentucky
  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
  69. Greensboro, North Carolina
  70. Lenoir, North Carolina
  71. Raleigh, North Carolina
  72. Winston-Salem, North Carolina
  73. Cincincinati, Ohio
  74. Cincinnati, Ohio
  75. Cleveland, Ohio
  76. Oklahoma City, Oklahoma
  77. Oklahoma City, Oklahoma
  78. Medford, Oregon
  79. Portland, Oregon
  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
  105. Salt Lake City, Utah
  106. Charlottesville, Virginia
  107. Norfolk, Virginia
  108. Richmond, Virginia
  109. Virginia Beach, Virginia
  110. Bellevue, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain
Official Title  ICMJE Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pain
Brief Summary The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: valdecoxib
    valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
  • Drug: diclofenac
    diclofenac 75 mg twice daily (BID) for 7 days
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: diclofenac
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: March 28, 2008)
340
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm
  • Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
  • History of at least 1 reported episode of acute low back pain in the last 5 years

Exclusion Criteria:

  • History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain
  • Moderate to severe scoliosis
  • Back pain due to major trauma or visceral disorder
  • Unwilling to refrain from commencing concomitant physiotherapy
  • Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication
  • Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation
  • Subject was pregnant or lactating woman , or was a woman of childbearing potential not using an acceptable method of contraception
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (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 Argentina,   Brazil,   Chile,   Colombia,   Costa Rica,   Ecuador,   Mexico,   Peru,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00649610
Other Study ID Numbers  ICMJE A3471012
Has Data Monitoring Committee No
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 March 2008

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