A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
Status and phase
Completed
Phase 3
Conditions
Laparoscopic Cholecystectomy
Pain
Treatments
Drug: valdecoxib
Drug: placebo
Details and patient eligibility
About
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.
Enrollment
490 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
490 participants in 3 patient groups, including a placebo group
Arm 1
Active Comparator group
Treatment:
Drug: valdecoxib
Drug: valdecoxib
Arm 2
Active Comparator group
Treatment:
Drug: valdecoxib
Drug: valdecoxib
Arm 3
Placebo Comparator group
Treatment:
Drug: placebo
Trial contacts and locations
65
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Data sourced from clinicaltrials.gov
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