A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Laparoscopic Cholecystectomy, Pain

In brief

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.

Key facts

Study ID: NCT00661635
Run by: Pfizer
People needed: 490
Starts: 2002-11-01
Expected to finish: 2003-07-01
Last updated by the study team: 2008-04-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Pfizer Investigational Site — Daphne, Alabama, United States
Pfizer Investigational Site — Fairhope, Alabama, United States
Pfizer Investigational Site — Mobile, Alabama, United States
Pfizer Investigational Site — Mobile, Alabama, United States
Pfizer Investigational Site — Sheffield, Alabama, United States
Pfizer Investigational Site — Glendale, Arizona, United States
Pfizer Investigational Site — Glendale, Arizona, United States
Pfizer Investigational Site — Phoenix, Arizona, United States
Pfizer Investigational Site — Phoenix, Arizona, United States
Pfizer Investigational Site — Phoenix, Arizona, United States
Pfizer Investigational Site — Phoenix, Arizona, United States
Pfizer Investigational Site — Tucson, Arizona, United States
Pfizer Investigational Site — Tucson, Arizona, United States
Pfizer Investigational Site — Tucson, Arizona, United States
Pfizer Investigational Site — Anaheim, California, United States
Pfizer Investigational Site — Bakersfield, California, United States
Pfizer Investigational Site — Bakersfield, California, United States
Pfizer Investigational Site — Los Angeles, California, United States
Pfizer Investigational Site — Los Angeles, California, United States
Pfizer Investigational Site — Pasadena, California, United States
Pfizer Investigational Site — Sacramento, California, United States
Pfizer Investigational Site — San Jose, California, United States
Pfizer Investigational Site — Woodland, California, United States
Pfizer Investigational Site — Miami, Florida, United States
Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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