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CompletedNCT00650598Updated Oct 8, 2008

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 Phase 4 interventional study of valdecoxib and diclofenac in Pain, Postoperative, sponsored by Pfizer. Completed at 25 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-08.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
328
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain, Postoperative

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Keywords

  • anterior cruciate ligament, arthroscopy, knee, post-surgical pain
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 328 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
328 participants (actual)

Study arms

  • Active comparator
    Arm 1

    Drug: valdecoxib

  • Active comparator
    Arm 2

    Drug: diclofenac

Interventions

  • Drugvaldecoxib

    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

  • Drugdiclofenac

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

06

What researchers measure

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

07

Study locations

25 sites
  • Pfizer Investigational Site
    Adelaide, South Australia SA 5000, Australia
  • Pfizer Investigational Site
    Hong Kong, Hong Kong
  • Pfizer Investigational Site
    Shatin, New Territories, Hong Kong
  • Pfizer Investigational Site
    Seoul, 110-744, Korea, Republic of
  • Pfizer Investigational Site
    Seoul, 138-736, Korea, Republic of
  • Pfizer Investigational Site
    Seoul, 140-757, Korea, Republic of
  • Pfizer Investigational Site
    Seoul, Korea, Republic of
  • Pfizer Investigational Site
    Cheras, Kuala Lumpur 56000, Malaysia
  • Pfizer Investigational Site
    Kuala Lumpur, Wilayah Persekutuan 50586, Malaysia
  • Pfizer Investigational Site
    Kuala Lumpur, Wilayah Persekutuan 59100, Malaysia
  • Pfizer Investigational Site
    Auckland, New Zealand
  • Pfizer Investigational Site
    Christchurch, New Zealand
  • Pfizer Investigational Site
    Wellington, New Zealand
  • Pfizer Investigational Site
    Manila, Philippines
  • Pfizer Investigational Site
    Quezon City, Philippines
  • Pfizer Investigational Site
    Quezon, Philippines
  • Pfizer Investigational Site
    Singapore, 529889, Singapore
  • Pfizer Investigational Site
    Kaohsiung, Taiwan
  • Pfizer Investigational Site
    Keelung, Taiwan
  • Pfizer Investigational Site
    Taipei, Taiwan
  • Pfizer Investigational Site
    Bangkok, 10330, Thailand
  • Pfizer Investigational Site
    Bangkok, 10400, Thailand
  • Pfizer Investigational Site
    Bangkok, 10700, Thailand
  • Pfizer Investigational Site
    Bangkok, Thailand
  • Pfizer Investigational Site
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00650598
Lead sponsor
Pfizer
First posted
Apr 2, 2008
Start date
Mar 2004
Primary completion
Aug 2004
Completion
Aug 2004
Last update
Oct 8, 2008

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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