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
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: valdecoxib (Drug); diclofenac (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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 release 75 mg BID in analgesic efficacy, in subjects undergoing knee
arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered
for 6 (±1) days.
Clinical Details
Official title: 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 Procedure for Anterior Cruciate Ligament Reconstruction
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Patient Assessment of Pain - Visual Analogue Scale
Secondary outcome: Global Evaluation of Study MedicationConsumption of Rescue Medication Modified Brief Pain Inventory - short form Effect on Pain Medication Questionnaire and Health Resource Utilization Adverse events Vital signs Physical examination
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Pfizer Investigational Site, Hong Kong, Hong Kong
Pfizer Investigational Site, Shatin, New Territories, Hong Kong
Pfizer Investigational Site, Seoul 110-744, Korea, Republic of
Pfizer Investigational Site, Seoul 138-736, Korea, Republic of
Pfizer Investigational Site, Unknown, Korea, Republic of
Pfizer Investigational Site, Seoul, Korea, Republic of
Pfizer Investigational Site, SEOUL 140-757, Korea, Republic of
Pfizer Investigational Site, Auckland, New Zealand
Pfizer Investigational Site, Wellington, New Zealand
Pfizer Investigational Site, Christchurch, New Zealand
Pfizer Investigational Site, Manila, Philippines
Pfizer Investigational Site, Quezon, Philippines
Pfizer Investigational Site, Quezon City, Philippines
Pfizer Investigational Site, Singapore 529889, Singapore
Pfizer Investigational Site, Unknown 169608, Singapore
Pfizer Investigational Site, Unknown 308433, Singapore
Pfizer Investigational Site, Kaohsiung, Taiwan
Pfizer Investigational Site, Keelung, Taiwan
Pfizer Investigational Site, Taipei, Taiwan
Pfizer Investigational Site, Bangkok 10700, Thailand
Pfizer Investigational Site, Bangkok 10400, Thailand
Pfizer Investigational Site, Bangkok, Thailand
Pfizer Investigational Site, Bangkok 10330, Thailand
Pfizer Investigational Site, Cheras, Kuala Lumpur 56000, Malaysia
Pfizer Investigational Site, Adelaide, South Australia SA 5000, Australia
Pfizer Investigational Site, Kuala Lumpur, Wilayah Persekutuan 59100, Malaysia
Pfizer Investigational Site, Kuala Lumpur, Wilayah Persekutuan 50586, Malaysia
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org posting:
Starting date: March 2004
Ending date: August 2004
Last updated: May 22, 2008
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