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
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
valdecoxib
diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring anterior cruciate ligament, arthroscopy, knee, post-surgical pain
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Patient Assessment of Pain - Visual Analogue Scale
Secondary Outcome Measures
Physical examination
Global Evaluation of Study Medication
Consumption of Rescue Medication
Modified Brief Pain Inventory - short form
Adverse events
Vital signs
Effect on Pain Medication Questionnaire and Health Resource Utilization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00650598
Brief 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 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
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
anterior cruciate ligament, arthroscopy, knee, post-surgical pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
328 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days
Primary Outcome Measure Information:
Title
Patient Assessment of Pain - Visual Analogue Scale
Time Frame
Days 1-6
Secondary Outcome Measure Information:
Title
Physical examination
Time Frame
Screening and Day 6
Title
Global Evaluation of Study Medication
Time Frame
Days 1-6
Title
Consumption of Rescue Medication
Time Frame
Days 1-6
Title
Modified Brief Pain Inventory - short form
Time Frame
Days 2-6
Title
Adverse events
Time Frame
Days 1-6
Title
Vital signs
Time Frame
Screening, Day 1, and Day 6
Title
Effect on Pain Medication Questionnaire and Health Resource Utilization
Time Frame
Days 2-6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
SA 5000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
140-757
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Auckland
Country
New Zealand
Facility Name
Pfizer Investigational Site
City
Christchurch
Country
New Zealand
Facility Name
Pfizer Investigational Site
City
Wellington
Country
New Zealand
Facility Name
Pfizer Investigational Site
City
Manila
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Quezon City
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Quezon
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Keelung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Bangkok
Country
Thailand
Facility Name
Pfizer Investigational Site
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3471039&StudyName=A%20Multicentre%2C%20Double-Blind%2C%20Double-Dummy%2C%20Randomised%20Study%20of%20the%20Analgesic%20Efficacy%20and%20Safety%20of%20Valdecoxib%20Compared%20to%20Diclofenac%20
Description
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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
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