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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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Adelaide, South Australia, SA 5000 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postoperative Pain
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

NCT00650598
Pfizer
Completed
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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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
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pain, Postoperative
  • 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
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: diclofenac
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
328
August 2004
August 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Hong Kong,   Korea, Republic of,   Malaysia,   New Zealand,   Philippines,   Singapore,   Taiwan,   Thailand
 
 
NCT00650598
A3471039
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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