Clinical trial NCT00650598: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: anterior cruciate ligament, arthroscopy, knee, post-surgical pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Patient Assessment of Pain - Visual Analogue Scale
timeFrame: Days 1-6
Secondary outcomes:
measure: Physical examination
timeFrame: Screening and Day 6
measure: Global Evaluation of Study Medication
timeFrame: Days 1-6
measure: Consumption of Rescue Medication
timeFrame: Days 1-6
measure: Modified Brief Pain Inventory - short form
timeFrame: Days 2-6
measure: Adverse events
timeFrame: Days 1-6
measure: Vital signs
timeFrame: Screening, Day 1, and Day 6
measure: Effect on Pain Medication Questionnaire and Health Resource Utilization
timeFrame: Days 2-6
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Shatin, New Territories
country: Hong Kong
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Cheras
country: Malaysia
facility: Pfizer Investigational Site
state: Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
state: Wilayah Persekutuan
city: Auckland
country: New Zealand
facility: Pfizer Investigational Site
city: Christchurch
country: New Zealand
facility: Pfizer Investigational Site
city: Wellington
country: New Zealand
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon
country: Philippines
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Keelung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: