A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for… (NCT00661635) | Clinical Trial Compass
CompletedPhase 3
A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
United States490 participantsStarted 2002-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Patient's Global Evaluation of Study Medication
Timeframe: Day 2 and Day 3
2
Summed Pain Intensity (categorical) through 24 hours (SPI 24)