Clinical Trial: A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Laparosc
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 Summary:
Sponsor: Pfizer
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: March 31, 2008
Date Started: November 2002
Date Completion:
Last Updated: April 21, 2008
Last Verified: March 2008