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CompletedNCT00653354Updated Dec 5, 2018

Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

A Phase 3 interventional study of valdecoxib and valdecoxib/placebo in Pain, Post-surgical, sponsored by Pfizer. Completed at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.

02

Conditions studied

  • Pain, Post-surgical

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Keywords

  • hallux valgus
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 360 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 underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) requiring open manipulation of bone with periosteal elevation under regional anesthesia (Mayo block)
  • Patients had a Baseline pain intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS

Exclusion criteria

Exclusion Criteria:

  • Patients who were scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
  • Patients treated with patient controlled analgesia (PCA) subsequent to the end of anesthesia
  • Patients treated with long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
  • Patients expected to require analgesics or other agents other than study medication during the 8 hours preceding administration of study medication through the end of the treatment period, that could confound assessment of the analgesic response, specifically excluded were tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, cyclooxygenase-2 inhibitors, nonsteroidal antiinflammatory drugs, and corticosteroids
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
360 participants (actual)

Study arms

  • Active comparator
    Arm 1

    Drug: valdecoxib

  • Active comparator
    Arm 2

    Drug: valdecoxib/placebo

  • Placebo comparator
    Arm 3

    Drug: placebo

Interventions

  • Drugvaldecoxib

    valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose

  • Drugvaldecoxib/placebo

    valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose

  • Drugplacebo

    placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose

06

What researchers measure

Primary outcomes

  1. Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24)

    Time frame: Day 1

  2. Total Pain Relief through 24 hours (TOTPAR 24)

    Time frame: Day 1

  3. Patient's Global Evaluation of Study Medication

    Time frame: Day 1

Secondary outcomes

  1. time between doses of study medication

    Time frame: Day 1

  2. Time-specific Pain Intensity Difference (PID) (categorical)

    Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours

  3. time-specific pain relief

    Time frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours

  4. time-specific PID (VAS)

    Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours

  5. Summed Pain Intensity (SPID)24 (VAS)

    Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours

  6. time to rescue medication

    Time frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours

  7. percent of patients who took rescue medication

    Time frame: Day 1

  8. Patient's Satisfaction Questionnaire

    Time frame: Day 1

07

Study locations

21 sites
  • Pfizer Investigational Site
    Phoenix, Arizona 85015, United States
  • Pfizer Investigational Site
    Phoenix, Arizona 85016, United States
  • Pfizer Investigational Site
    Phoenix, Arizona 85020, United States
  • Pfizer Investigational Site
    Phoenix, Arizona 85032, United States
  • Pfizer Investigational Site
    Tempe, Arizona 85281, United States
  • Pfizer Investigational Site
    Anaheim, California 92701, United States
  • Pfizer Investigational Site
    Chula Vista, California 91911, United States
  • Pfizer Investigational Site
    San Diego, California 92114, United States
  • Pfizer Investigational Site
    Santa Ana, California 92701, United States
  • Pfizer Investigational Site
    Tustin, California 92780, United States
  • Pfizer Investigational Site
    Lexington, Kentucky 40504, United States
  • Pfizer Investigational Site
    Lexington, Kentucky 40509, United States
  • Pfizer Investigational Site
    Lexington, Kentucky 40515, United States
  • Pfizer Investigational Site
    Altoona, Pennsylvania 16602, United States
  • Pfizer Investigational Site
    Duncansville, Pennsylvania 16635, United States
  • Pfizer Investigational Site
    Johnson City, Tennessee 37601, United States
  • Pfizer Investigational Site
    Johnson City, Tennessee 37604, United States
  • Pfizer Investigational Site
    San Antonio, Texas 78229, United States
  • Pfizer Investigational Site
    San Antonio, Texas 78240, United States
  • Pfizer Investigational Site
    Salt Lake City, Utah 84117, United States
  • Pfizer Investigational Site
    Salt Lake City, Utah 84123, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00653354
Lead sponsor
Pfizer
First posted
Apr 4, 2008
Start date
Dec 2002
Completion
Mar 2003
Last update
Dec 5, 2018

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 Dec 2018. You cannot join it, but the record below documents what was studied.

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