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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2
• Placebo Comparator: Arm 3

Primary Measures

• Patient's Global Evaluation of Study Medication
  • Time Frame: Day 2 and Day 3
    Safety Issue?: No
• Summed Pain Intensity (categorical) through 24 hours (SPI 24)
  • Time Frame: Day 2 and Day 3
    Safety Issue?: No

Secondary Measures

• Time-specific PI (VAS)
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Patient's Global Evaluation of Study Medication
  • Time Frame: Day 4 and Day 5
    Safety Issue?: No
• Time to first dose of rescue medication
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Percent of patients who took rescue medication on each study day
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Amount of rescue medication taken
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Time between doses of study medication
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Worst PI (derived from the mBPI-SF)
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• Average PI (derived from the mBPI-SF)
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• SPI 24 (categorical)
  • Time Frame: Day 4 and Day 5
    Safety Issue?: No
• Time-specific PI (categorical)
  • Time Frame: Days 2 to 5
    Safety Issue?: No
• SPI 24 (VAS)
  • Time Frame: Days 2 to 5
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00661635

Study ID Number: VALA-0513-145

ClinicalTrials.gov Identifier: NCT00661635

Health Authority: United States: Institutional Review Board

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