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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: valdecoxib; Drug: diclofenac

• Registration Number: NCT00650598
• Lead Sponsor: Pfizer

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-02
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-06
• Last Update Posted: 2008-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	valdecoxib	-
Arm 2	diclofenac	-

Primary Outcome Measures

Name	Time	Method
Patient Assessment of Pain - Visual Analogue Scale	Days 1-6

Secondary Outcome Measures

Name	Time	Method
Physical examination	Screening and Day 6
Global Evaluation of Study Medication	Days 1-6
Consumption of Rescue Medication	Days 1-6
Modified Brief Pain Inventory - short form	Days 2-6
Adverse events	Days 1-6
Vital signs	Screening, Day 1, and Day 6
Effect on Pain Medication Questionnaire and Health Resource Utilization	Days 2-6

Trial Locations

Locations (1)

Pfizer Investigational Site