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...
Date First Received: March 31, 2008
Last Updated: April 21, 2008
Verified by: Pfizer, March 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2002
Overall Status: Completed
Estimated Enrollment: 490
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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
Outcome Measures for this Clinical Trial
Primary Measures
- Patient's Global Evaluation of Study Medication
- Time Frame: Day 2 and Day 3
Safety Issue?: No
- Time Frame: Day 2 and Day 3
- Summed Pain Intensity (categorical) through 24 hours (SPI 24)
- Time Frame: Day 2 and Day 3
Safety Issue?: No
- Time Frame: Day 2 and Day 3
Secondary Measures
- Time-specific PI (VAS)
- Time Frame: Days 2 to 5
Safety Issue?: No
- Time Frame: Days 2 to 5
- Patient's Global Evaluation of Study Medication
- Time Frame: Day 4 and Day 5
Safety Issue?: No
- Time Frame: Day 4 and Day 5
- Time to first dose of rescue medication
- Time Frame: Days 2 to 5
Safety Issue?: No
- Time Frame: Days 2 to 5
- Percent of patients who took rescue medication on each study day
- Time Frame: Days 2 to 5
Safety Issue?: No
- Time Frame: Days 2 to 5
- Amount of rescue medication taken
- Time Frame: Days 2 to 5
Safety Issue?: No
- Time Frame: Days 2 to 5
- Time between doses of study medication
- Time Frame: Days 2 to 5
Safety Issue?: No
- Time Frame: Days 2 to 5
- Worst PI (derived from the mBPI-SF)
- Time Frame: Days 2 to 5
Safety Issue?: No
- Time Frame: Days 2 to 5
- Average PI (derived from the mBPI-SF)
- Time Frame: Days 2 to 5
Safety Issue?: No
- Time Frame: Days 2 to 5
- SPI 24 (categorical)
- Time Frame: Day 4 and Day 5
Safety Issue?: No
- Time Frame: Day 4 and Day 5
- Time-specific PI (categorical)
- Time Frame: Days 2 to 5
Safety Issue?: No
- Time Frame: Days 2 to 5
- SPI 24 (VAS)
- Time Frame: Days 2 to 5
Safety Issue?: No
- Time Frame: Days 2 to 5
Criteria for Participation 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 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
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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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