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

NCT00650598

Last updated date
Study Location
Pfizer Investigational Site
Adelaide, South Australia, SA 5000, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain, Postoperative
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pain, PostoperativeA 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
NCT00650598
  1. Adelaide, South Australia
  2. Hong Kong,
  3. Shatin, New Territories,
  4. Seoul,
  5. Seoul,
  6. Seoul,
  7. Seoul,
  8. Cheras, Kuala Lumpur
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  12. Christchurch,
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  22. Bangkok,
  23. Bangkok,
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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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
  • Drug: diclofenac
    diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: diclofenac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2008)
328
Original Actual Enrollment  ICMJE
 (submitted: April 1, 2008)
312
Actual Study Completion Date  ICMJE August 2004
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Hong Kong,   Korea, Republic of,   Malaysia,   New Zealand,   Philippines,   Singapore,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00650598
Other Study ID Numbers  ICMJE A3471039
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP