Status:
COMPLETED
A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
Lead Sponsor:
Pfizer
Conditions:
Laparoscopic Cholecystectomy
Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT00661635
Start Date
November 1 2002
End Date
July 1 2003
Last Update
April 23 2008
Active Locations (65)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35213
2
Pfizer Investigational Site
Daphne, Alabama, United States, 36526
3
Pfizer Investigational Site
Fairhope, Alabama, United States, 36532
4
Pfizer Investigational Site
Mobile, Alabama, United States, 36617