Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

NCT00683137

Last updated date
Study Location
Pfizer Investigational Site
Chandler, Arizona, 85224, 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.
Pain, Hallux Valgus
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

- Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)

- Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm

- Patients with a baseline pain intensity (categorical) of moderate or severe

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


- Patients scheduled to undergo other surgical procedures that would be expected to
produce a greater degree of surgical trauma than the orthopedic procedure alone


- Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia


- Long-acting local anesthetics or local anesthetics coadministered with epinephrine
injected into the index joint space


- Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic
antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids


- Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to
abstain from NSAIDs or other analgesics, except as specified in the protocol, during
the study

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Pain, Hallux ValgusAnalgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery
NCT00683137
  1. Chandler, Arizona
  2. Glendale, Arizona
  3. Glendale, Arizona
  4. Mesa, Arizona
  5. Phoenix, Arizona
  6. Phoenix, Arizona
  7. Phoenix, Arizona
  8. Phoenix, Arizona
  9. Phoenix, Arizona
  10. Phoenix, Arizona
  11. National City, California
  12. San Diego, California
  13. San Diego, California
  14. San Diego, California
  15. San Diego, California
  16. Milford, Connecticut
  17. New Haven, Connecticut
  18. New Haven, Connecticut
  19. Cooper City, Florida
  20. Cutler Ridge, Florida
  21. Fort Lauderdale, Florida
  22. Ft. Lauderdale, Florida
  23. Ft. Lauderdale, Florida
  24. Hallandale, Florida
  25. Hollywood, Florida
  26. Hollywood, Florida
  27. Miami, Florida
  28. New Port Richey, Florida
  29. New Port Richey, Florida
  30. New Port Richey, Florida
  31. Pembroke Pines, Florida
  32. Pembroke Pines, Florida
  33. Port Richey, Florida
  34. South Miami, Florida
  35. Spring Hill, Florida
  36. Addison, Illinois
  37. Elk Grove Village, Illinois
  38. Peoria, Illinois
  39. Peoria, Illinois
  40. Peoria, Illinois
  41. Evansville, Indiana
  42. New Orleans, Louisiana
  43. New Orleans, Louisiana
  44. Annapolis, Maryland
  45. Chester, Maryland
  46. Omaha, Nebraska
  47. Omaha, Nebraska
  48. Omaha, Nebraska
  49. Las Vegas, Nevada
  50. Las Vegas, Nevada
  51. Las Vegas, Nevada
  52. Las Vegas, Nevada
  53. Las Vegas, Nevada
  54. Bismarck, North Dakota
  55. Austintown, Ohio
  56. Canfield, Ohio
  57. Cleveland, Ohio
  58. Youngstown, Ohio
  59. Youngstown, Ohio
  60. Portland, Oregon
  61. Altoona, Pennsylvania
  62. Altoona, Pennsylvania
  63. Duncansville, Pennsylvania
  64. Havertown, Pennsylvania
  65. Media, Pennsylvania
  66. Philadelphia, Pennsylvania
  67. Philadelphia, Pennsylvania
  68. Philadelphia, Pennsylvania
  69. Reading, Pennsylvania
  70. State College, Pennsylvania
  71. Upland, Pennsylvania
  72. Wyomissig, Pennsylvania
  73. Greer, South Carolina
  74. Austin, Texas
  75. Austin, Texas
  76. San Antonio, Texas
  77. San Antonio, Texas
  78. San Antonio, Texas
  79. San Antonio, Texas
  80. Holladay, Utah
  81. Layton, Utah
  82. Provo, Utah
  83. Salt Lake City, Utah
  84. Salt Lake City, Utah
  85. Salt Lake City, Utah
  86. Salt Lake City, Utah
  87. Salt Lake City, Utah
  88. Sandy, Utah
  89. St. George, Utah
  90. Tacoma, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery
Official Title  ICMJE Clinical Protocol for a Multiple Dose Randomized, Double-Blind, Placebo Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Bunionectomy Surgery
Brief Summary The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.
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
  • Pain
  • Hallux Valgus
Intervention  ICMJE
  • Drug: valdecoxib
    valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5
  • Drug: valdecoxib
    valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth twice daily on Days 2 through 5
  • Drug: valdecoxib/placebo
    valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then placebo on Days 2 through 5
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 3
    Intervention: Drug: valdecoxib/placebo
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 22, 2008)
450
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
  • Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
  • Patients with a baseline pain intensity (categorical) of moderate or severe

Exclusion Criteria:

  • Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
  • Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
  • Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
  • Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
  • Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00683137
Other Study ID Numbers  ICMJE VALA-0513-144
A3471084
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 May 2008

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