A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain

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NCT00661635

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35213, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Laparoscopic Cholecystectomy, Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm)

- Patients were able to get their first dose of study medication within 8 hours after the end of surgery

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


- Patients could not undergo procedures expected to produce a greater degree of surgical
trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain
(other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic
conditions, nor cancer, nor a laboratory abnormality that the investigator considered
to contraindicate study participation


- Patient had any cognitive impairment that would, in the investigator's opinion,
preclude study participation or compliance with protocol mandated procedures


- Patient had a history of known alcohol, analgesic, or narcotic substance abuse within
the one year prior to Screening


- Patient had any laboratory abnormality at screening, that, in the opinion of the
investigator, is not due to the condition requiring surgery and is not expected to
resolve post-surgery, and would, therefore, contraindicate study participation

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Laparoscopic Cholecystectomy, PainA Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
NCT00661635
  1. Birmingham, Alabama
  2. Daphne, Alabama
  3. Fairhope, Alabama
  4. Mobile, Alabama
  5. Mobile, Alabama
  6. Sheffield, Alabama
  7. Glendale, Arizona
  8. Glendale, Arizona
  9. Phoenix, Arizona
  10. Phoenix, Arizona
  11. Phoenix, Arizona
  12. Phoenix, Arizona
  13. Tucson, Arizona
  14. Tucson, Arizona
  15. Tucson, Arizona
  16. Anaheim, California
  17. Bakersfield, California
  18. Bakersfield, California
  19. Los Angeles, California
  20. Los Angeles, California
  21. Pasadena, California
  22. Sacramento, California
  23. San Jose, California
  24. Woodland, California
  25. Miami, Florida
  26. Miami, Florida
  27. Pensacola, Florida
  28. Blue Ridge, Georgia
  29. Marietta, Georgia
  30. Chicago, Illinois
  31. Maywood, Illinois
  32. Iowa City, Iowa
  33. Shreveport, Louisiana
  34. Baltimore, Maryland
  35. Germantown, Maryland
  36. Rockville, Maryland
  37. Silver Spring, Maryland
  38. Jackson, Mississippi
  39. Durham, North Carolina
  40. Winston-Salem, North Carolina
  41. Winston-Salem, North Carolina
  42. Oklahoma City, Oklahoma
  43. Allentown, Pennsylvania
  44. Philadelphia, Pennsylvania
  45. Pittsburgh, Pennsylvania
  46. Charleston, South Carolina
  47. Columbia, South Carolina
  48. Columbia, South Carolina
  49. Mt. Pleasant, South Carolina
  50. North Charleston, South Carolina
  51. Summerville, South Carolina
  52. Bristol, Tennessee
  53. Kingsport, Tennessee
  54. Houston, Texas
  55. Houston, Texas
  56. San Antonio, Texas
  57. Universal City, Texas
  58. Sandy, Utah
  59. Sandy, Utah
  60. West Jordan, Utah
  61. Norfolk, Virginia
  62. Suffolk, Virginia
  63. Renton, Washington
  64. Renton, Washington
  65. Madison, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
Official Title  ICMJE 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 Laparoscopic Cholecystectomy Surgery
Brief Summary To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Laparoscopic Cholecystectomy
  • Pain
Intervention  ICMJE
  • Drug: placebo
    valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5
  • Drug: valdecoxib
    valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
  • Drug: valdecoxib
    valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: valdecoxib
  • Placebo Comparator: Arm 3
    Intervention: Drug: 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: April 15, 2008)		490
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ?45 mm on a VAS (100 mm)
  • Patients were able to get their first dose of study medication within 8 hours after the end of surgery

Exclusion Criteria:

  • Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation
  • Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures
  • Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening
  • Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00661635
Other Study ID Numbers  ICMJE VALA-0513-145
A3471085
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