You are here

Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction

Last updated on February 21, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Show details

- Included patients had uncomplicated arthroscopic ACL reconstruction

- Subjects were to have a Baseline pain intensity of ≥ 50 mm as measured on a 0 - 100mm
visual analogue scale (VAS) and moderate to severe pain on a categorical scale by
23:00 hours on the day of surgery and prior to being discharged from the surgical
facility

- Subjects could not have received any medication or additional procedures that would
confound the interpretation of the study results.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- the patient was admitted to or retained in the surgical center/hospital for >23 hours;

- the patient underwent any other surgical procedure, along with the orthopedic
procedure, that was expected to produce a greater degree of surgical trauma than the
orthopedic procedure alone;

- the patient used conventional nonsteroidal antiinflammatory drugs (NSAIDs), selective
cyclooxygenase-2 (COX-2) inhibitors, or tramadol during the 6 hours preceding surgery,
during surgery, or subsequent to the end of surgery;

- the patient received oxaprozin or piroxicam within 1 week prior to randomization;

- the patient had a pain pump or indwelling catheter during surgery that administered
local or intraarticular anesthetics or narcotics at the index joint, or had such an
intra-articular injection at the end of surgery;

- the patient had been treated with patient-controlled analgesia or NSAIDs subsequent to
the end of anesthesia;

- patient had a history of clinically significant GI disease or renal disease, or
history of a gastrointestinal ulcer, or cancer, or a laboratory abnormality that would
suggest it was not in the subject's best interest to enroll in the trial.

NCT00650039
Pfizer
Completed
Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now