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Completed

NCT Number: NCT00650598

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Adelaide, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valdecoxib

Drug

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

Diclofenac

Drug

diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days

Primary outcomes

  1. Patient Assessment of Pain - Visual Analogue Scale

    Time frame: Days 1-6

Secondary outcomes

  1. Physical examination

    Time frame: Screening and Day 6

  2. Global Evaluation of Study Medication

    Time frame: Days 1-6

  3. Consumption of Rescue Medication

    Time frame: Days 1-6

  4. Modified Brief Pain Inventory - short form

    Time frame: Days 2-6

  5. Adverse events

    Time frame: Days 1-6

  6. Vital signs

    Time frame: Screening, Day 1, and Day 6

  7. Effect on Pain Medication Questionnaire and Health Resource Utilization

    Time frame: Days 2-6

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Apr 2, 2008
Registry last updated
Oct 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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