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 May 11, 2018

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 zip code, city, or country to find studies near you.

Similar Trials

Low Back Pain
NCT02528253
All Genders
18+
Years
Multiple Sites
Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
NCT02433158
All Genders
6+
Years
Multiple Sites
Pain
NCT01266161
All Genders
16+
Years
Multiple Sites
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
A Multicenter, Double-Blind, Placebo-Controlled, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg QD And Valdecoxib 20 Mg BID Compared To Placebo Over Multiple Days For Management Of Acute Postsurgical Pain In Patients Undergoing Anterior Cruciate Ligament Reconstruction
The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: placebo
    valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5.
  • Drug: valdecoxib
    valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.
  • Drug: valdecoxib
    valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: valdecoxib
  • Placebo Comparator: Arm 3
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
February 2005
Not Provided

Inclusion Criteria:

  • 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 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00650039
A3471109
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now