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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35213 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Laparoscopic Cholecystectomy, Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00661635
Pfizer
Completed
A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain

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Pfizer Clinical Trials Contact Center

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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