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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00650598
First received: March 31, 2008
Last updated: October 6, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Drug: valdecoxib
Drug: diclofenac
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Patient Assessment of Pain - Visual Analogue Scale [ Time Frame: Days 1-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical examination [ Time Frame: Screening and Day 6 ] [ Designated as safety issue: Yes ]
  • Global Evaluation of Study Medication [ Time Frame: Days 1-6 ] [ Designated as safety issue: No ]
  • Consumption of Rescue Medication [ Time Frame: Days 1-6 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory - short form [ Time Frame: Days 2-6 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Days 1-6 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Screening, Day 1, and Day 6 ] [ Designated as safety issue: Yes ]
  • Effect on Pain Medication Questionnaire and Health Resource Utilization [ Time Frame: Days 2-6 ] [ Designated as safety issue: No ]

Enrollment: 328
Study Start Date: March 2004
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 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
Active Comparator: Arm 2 Drug: diclofenac
diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650598

Locations
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, SA 5000
Hong Kong
Pfizer Investigational Site
Hong Kong, Hong Kong
Pfizer Investigational Site
Shatin, New Territories, Hong Kong
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 140-757
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Unknown, Korea, Republic of
Malaysia
Pfizer Investigational Site
Cheras, Kuala Lumpur, Malaysia, 56000
Pfizer Investigational Site
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Pfizer Investigational Site
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
New Zealand
Pfizer Investigational Site
Auckland, New Zealand
Pfizer Investigational Site
Christchurch, New Zealand
Pfizer Investigational Site
Wellington, New Zealand
Philippines
Pfizer Investigational Site
Manila, Philippines
Pfizer Investigational Site
Quezon, Philippines
Pfizer Investigational Site
Quezon City, Philippines
Singapore
Pfizer Investigational Site
Singapore, Singapore, 529889
Pfizer Investigational Site
Unknown, Singapore, 169608
Pfizer Investigational Site
Unknown, Singapore, 308433
Taiwan
Pfizer Investigational Site
Kaohsiung, Taiwan
Pfizer Investigational Site
Keelung, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Thailand
Pfizer Investigational Site
Bangkok, Thailand, 10700
Pfizer Investigational Site
Bangkok, Thailand, 10330
Pfizer Investigational Site
Bangkok, Thailand
Pfizer Investigational Site
Bangkok, Thailand, 10400
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00650598     History of Changes
Other Study ID Numbers: A3471039
Study First Received: March 31, 2008
Last Updated: October 6, 2008
Health Authority: Malaysia: Ministry of Health

Keywords provided by Pfizer:
anterior cruciate ligament, arthroscopy, knee, post-surgical pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Valdecoxib
Diclofenac
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2014