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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)

Interventions

  • 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

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

Clinical Trial Outcome Measures

Primary Measures

  • Patient’s Global Evaluation of Study Medication
    • Time Frame: Day 2 and Day 3
  • Summed Pain Intensity (categorical) through 24 hours (SPI 24)
    • Time Frame: Day 2 and Day 3

Secondary Measures

  • Time-specific PI (VAS)
    • Time Frame: Days 2 to 5
  • Patient’s Global Evaluation of Study Medication
    • Time Frame: Day 4 and Day 5
  • Time to first dose of rescue medication
    • Time Frame: Days 2 to 5
  • Percent of patients who took rescue medication on each study day
    • Time Frame: Days 2 to 5
  • Amount of rescue medication taken
    • Time Frame: Days 2 to 5
  • Time between doses of study medication
    • Time Frame: Days 2 to 5
  • Worst PI (derived from the mBPI-SF)
    • Time Frame: Days 2 to 5
  • Average PI (derived from the mBPI-SF)
    • Time Frame: Days 2 to 5
  • SPI 24 (categorical)
    • Time Frame: Day 4 and Day 5
  • Time-specific PI (categorical)
    • Time Frame: Days 2 to 5
  • SPI 24 (VAS)
    • Time Frame: Days 2 to 5

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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