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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00650598




Registration number
NCT00650598
Ethics application status
Date submitted
31/03/2008
Date registered
2/04/2008
Date last updated
8/10/2008

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
A3471039
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Postoperative 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - valdecoxib
Treatment: Drugs - diclofenac

Active Comparator: Arm 1 -

Active Comparator: Arm 2 -


Treatment: Drugs: 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

Treatment: Drugs: diclofenac
diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient Assessment of Pain - Visual Analogue Scale
Timepoint [1] 0 0
Days 1-6
Secondary outcome [1] 0 0
Physical examination
Timepoint [1] 0 0
Screening and Day 6
Secondary outcome [2] 0 0
Global Evaluation of Study Medication
Timepoint [2] 0 0
Days 1-6
Secondary outcome [3] 0 0
Consumption of Rescue Medication
Timepoint [3] 0 0
Days 1-6
Secondary outcome [4] 0 0
Modified Brief Pain Inventory - short form
Timepoint [4] 0 0
Days 2-6
Secondary outcome [5] 0 0
Adverse events
Timepoint [5] 0 0
Days 1-6
Secondary outcome [6] 0 0
Vital signs
Timepoint [6] 0 0
Screening, Day 1, and Day 6
Secondary outcome [7] 0 0
Effect on Pain Medication Questionnaire and Health Resource Utilization
Timepoint [7] 0 0
Days 2-6

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2004
Sample size
Target
Accrual to date
Final
328
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Shatin, New Territories
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Malaysia
State/province [4] 0 0
Kuala Lumpur
Country [5] 0 0
Malaysia
State/province [5] 0 0
Wilayah Persekutuan
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
New Zealand
State/province [7] 0 0
Christchurch
Country [8] 0 0
New Zealand
State/province [8] 0 0
Wellington
Country [9] 0 0
Philippines
State/province [9] 0 0
Manila
Country [10] 0 0
Philippines
State/province [10] 0 0
Quezon City
Country [11] 0 0
Philippines
State/province [11] 0 0
Quezon
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore
Country [13] 0 0
Taiwan
State/province [13] 0 0
Kaohsiung
Country [14] 0 0
Taiwan
State/province [14] 0 0
Keelung
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taipei
Country [16] 0 0
Thailand
State/province [16] 0 0
Bangkok
Country [17] 0 0
State/province [17] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00650598
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00650598