Status:
COMPLETED
A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction
Lead Sponsor:
Pfizer
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed rel...
Eligibility Criteria
Inclusion
- Patients who had undergone an uncomplicated ACL reconstruction procedure and were in satisfactory health were included in the study
- In addition, they needed to have a baseline pain intensity of ≥ 50 mm on the VAS and "moderate to severe" pain on the categorical scale within 8 hours of the completion of the surgical procedure to be included
Exclusion
- Patient was scheduled to undergo 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 was undergoing bilateral knee arthroscopy
- The patient used conventional NSAIDs, COX-2 inhibitors, or Tramadol during the 6 hours preceding surgery, during surgery or subsequent to the end of surgery, until randomization
- The patient received oxaprozin or piroxicam within one week prior to randomization
- The patient was required to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics and neuroleptics, in the post operative period after the patient was randomized into the study
- The patient had been treated with patient controlled analgesia subsequent to the end of the surgical procedure
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT00650598
Start Date
March 1 2004
End Date
August 1 2004
Last Update
October 8 2008
Active Locations (25)
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1
Pfizer Investigational Site
Adelaide, South Australia, Australia, SA 5000
2
Pfizer Investigational Site
Hong Kong, Hong Kong
3
Pfizer Investigational Site
Shatin, New Territories, Hong Kong
4
Pfizer Investigational Site
Cheras, Kuala Lumpur, Malaysia, 56000