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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650598
• Other study ID #: A3471039
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2008
• Last updated: October 6, 2008
• Start date: March 2004
• Est. completion date: August 2004

Study information

• Verified date: October 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• valdecoxib
valdecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6
• diclofenac
diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Adelaide	South Australia
Hong Kong	Pfizer Investigational Site	Hong Kong
Hong Kong	Pfizer Investigational Site	Shatin, New Territories
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Unknown
Malaysia	Pfizer Investigational Site	Cheras	Kuala Lumpur
Malaysia	Pfizer Investigational Site	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Pfizer Investigational Site	Kuala Lumpur	Wilayah Persekutuan
New Zealand	Pfizer Investigational Site	Auckland
New Zealand	Pfizer Investigational Site	Christchurch
New Zealand	Pfizer Investigational Site	Wellington
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Quezon
Philippines	Pfizer Investigational Site	Quezon City
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Unknown
Singapore	Pfizer Investigational Site	Unknown
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Keelung
Taiwan	Pfizer Investigational Site	Taipei
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Hong Kong,  Korea, Republic of,  Malaysia,  New Zealand,  Philippines,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Assessment of Pain - Visual Analogue Scale		Days 1-6	No
Secondary	Physical examination		Screening and Day 6	Yes
Secondary	Global Evaluation of Study Medication		Days 1-6	No
Secondary	Consumption of Rescue Medication		Days 1-6	No
Secondary	Modified Brief Pain Inventory - short form		Days 2-6	No
Secondary	Adverse events		Days 1-6	Yes
Secondary	Vital signs		Screening, Day 1, and Day 6	Yes
Secondary	Effect on Pain Medication Questionnaire and Health Resource Utilization		Days 2-6	No

External Links

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