Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.

NCT00290901

Last updated date
Study Location
Pfizer Investigational Site
Phoenix, Arizona, , 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.
Back Pain
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

- The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used.

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


- The subject has chronic low back pain, which is neurologic in etiology (i.e.,
radiculopathy, neuropathy, myelopathy)

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Back PainCelebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.
NCT00290901
  1. Phoenix, Arizona
  2. Scottsdale, Arizona
  3. Tucson, Arizona
  4. Little Rock, Arkansas
  5. Anaheim, California
  6. La Mesa, California
  7. Long Beach, California
  8. Oceanside, California
  9. Paramount, California
  10. Sacramento, California
  11. San Francisco, California
  12. San Luis Obispo, California
  13. Tustin, California
  14. Vista, California
  15. Boulder, Colorado
  16. Colorado Springs, Colorado
  17. Denver, Colorado
  18. Cos Cob, Connecticut
  19. Washington, District of Columbia
  20. Miami, Florida
  21. Pembroke Pines, Florida
  22. West Palm Beach, Florida
  23. Decatur, Georgia
  24. Woodstock, Georgia
  25. Libertyville, Illinois
  26. Morton Grove, Illinois
  27. Arkansas City, Kansas
  28. Overland Park, Kansas
  29. Wichita, Kansas
  30. Madisonville, Kentucky
  31. Baltimore, Maryland
  32. Wheaton, Maryland
  33. Jackson, Mississippi
  34. Kansas City, Missouri
  35. St. Louis, Missouri
  36. Omaha, Nebraska
  37. Brooklyn, New York
  38. New York, New York
  39. Rochester, New York
  40. Raleigh, North Carolina
  41. Medford, Oregon
  42. Portland, Oregon
  43. Camp Hill, Pennsylvania
  44. Duncansville, Pennsylvania
  45. Charleston, South Carolina
  46. Columbia, South Carolina
  47. Johnson City, Tennessee
  48. New Tazewell, Tennessee
  49. Austin, Texas
  50. San Angelo, Texas
  51. San Antonio, Texas
  52. Arlington, Virginia
  53. Danville, Virginia
  54. Rio Piedras,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.
Official Title  ICMJE A Six Week Double-Blind, Randomized, Multicenter Comparison Study of the Analgesic Effectiveness of Celecoxib 200 mg BID Compared to Tramadol Hydrochloride 50 mg QID in Subjects With Chronic Low Back Pain
Brief Summary This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Back Pain
Intervention  ICMJE
  • Drug: Tramadol Hydrochloride 50mg
  • Drug: Celebrex 200mg
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
Enrollment  ICMJE
 (submitted: February 9, 2006)
754
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used.

Exclusion Criteria:

  • The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00290901
Other Study ID Numbers  ICMJE A3191165
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 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