Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

Clinical Protocol for a Multiple Dose Randomized, Double-Blind, Placebo Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Bunionectomy Surgery

The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.

Study Overview

• Status: Completed
• Conditions: Pain; Hallux Valgus
• Intervention / Treatment: Drug: valdecoxib; Drug: valdecoxib; Drug: valdecoxib/placebo

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Pfizer Investigational Site
    • Glendale, Arizona, United States, 85306
      • Pfizer Investigational Site
    • Glendale, Arizona, United States, 85302
      • Pfizer Investigational Site
    • Mesa, Arizona, United States, 85204
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85016
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85023
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85012
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85015
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 58029
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85022
      • Pfizer Investigational Site
  • California
    • National City, California, United States, 91950
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103
      • Pfizer Investigational Site
    • San Diego, California, United States, 92116
      • Pfizer Investigational Site
    • San Diego, California, United States, 92114
      • Pfizer Investigational Site
    • San Diego, California, United States, 91950
      • Pfizer Investigational Site
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Pfizer Investigational Site
    • New Haven, Connecticut, United States, 06515
      • Pfizer Investigational Site
    • New Haven, Connecticut, United States, 6515
      • Pfizer Investigational Site
  • Florida
    • Cooper City, Florida, United States, 33330
      • Pfizer Investigational Site
    • Cutler Ridge, Florida, United States, 33157
      • Pfizer Investigational Site
    • Fort Lauderdale, Florida, United States, 33308
      • Pfizer Investigational Site
    • Ft. Lauderdale, Florida, United States, 33308
      • Pfizer Investigational Site
    • Ft. Lauderdale, Florida, United States, 33306
      • Pfizer Investigational Site
    • Hallandale, Florida, United States, 33009
      • Pfizer Investigational Site
    • Hollywood, Florida, United States, 33021
      • Pfizer Investigational Site
    • Hollywood, Florida, United States, 33020
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33180
      • Pfizer Investigational Site
    • New Port Richey, Florida, United States, 34655
      • Pfizer Investigational Site
    • New Port Richey, Florida, United States, 34652
      • Pfizer Investigational Site
    • New Port Richey, Florida, United States, 34653
      • Pfizer Investigational Site
    • Pembroke Pines, Florida, United States, 33028
      • Pfizer Investigational Site
    • Pembroke Pines, Florida, United States, 33027
      • Pfizer Investigational Site
    • Port Richey, Florida, United States, 34668
      • Pfizer Investigational Site
    • South Miami, Florida, United States, 33143
      • Pfizer Investigational Site
    • Spring Hill, Florida, United States, 34608
      • Pfizer Investigational Site
  • Illinois
    • Addison, Illinois, United States, 60101
      • Pfizer Investigational Site
    • Elk Grove Village, Illinois, United States, 60007
      • Pfizer Investigational Site
    • Peoria, Illinois, United States, 61614
      • Pfizer Investigational Site
    • Peoria, Illinois, United States, 61615
      • Pfizer Investigational Site
    • Peoria, Illinois, United States, 61602
      • Pfizer Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Pfizer Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70128
      • Pfizer Investigational Site
    • New Orleans, Louisiana, United States, 70127
      • Pfizer Investigational Site
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Pfizer Investigational Site
    • Chester, Maryland, United States, 21619
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Pfizer Investigational Site
    • Omaha, Nebraska, United States, 68134
      • Pfizer Investigational Site
    • Omaha, Nebraska, United States, 68144
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89102
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89106
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89121
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89104
      • Pfizer Investigational Site
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Pfizer Investigational Site
  • Ohio
    • Austintown, Ohio, United States, 44515
      • Pfizer Investigational Site
    • Canfield, Ohio, United States, 44406
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States, 44106
      • Pfizer Investigational Site
    • Youngstown, Ohio, United States, 44512
      • Pfizer Investigational Site
    • Youngstown, Ohio, United States, 44515
      • Pfizer Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97205
      • Pfizer Investigational Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Pfizer Investigational Site
    • Altoona, Pennsylvania, United States
      • Pfizer Investigational Site
    • Duncansville, Pennsylvania, United States, 16635
      • Pfizer Investigational Site
    • Havertown, Pennsylvania, United States, 19083
      • Pfizer Investigational Site
    • Media, Pennsylvania, United States, 19063
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19140
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107-2496
      • Pfizer Investigational Site
    • Reading, Pennsylvania, United States, 19606
      • Pfizer Investigational Site
    • State College, Pennsylvania, United States, 16803
      • Pfizer Investigational Site
    • Upland, Pennsylvania, United States, 19013
      • Pfizer Investigational Site
    • Wyomissig, Pennsylvania, United States, 19610
      • Pfizer Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78756
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78731
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78209
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78240
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78205
      • Pfizer Investigational Site
    • San Antonio, Texas, United States
      • Pfizer Investigational Site
  • Utah
    • Holladay, Utah, United States, 84117
      • Pfizer Investigational Site
    • Layton, Utah, United States, 84041
      • Pfizer Investigational Site
    • Provo, Utah, United States, 84054
      • Pfizer Investigational Site
    • Salt Lake City, Utah, United States, 84124
      • Pfizer Investigational Site
    • Salt Lake City, Utah, United States, 84102
      • Pfizer Investigational Site
    • Salt Lake City, Utah, United States, 84107
      • Pfizer Investigational Site
    • Salt Lake City, Utah, United States, 84117
      • Pfizer Investigational Site
    • Salt Lake City, Utah, United States, 84157-0667
      • Pfizer Investigational Site
    • Sandy, Utah, United States, 84070
      • Pfizer Investigational Site
    • St. George, Utah, United States, 84770
      • Pfizer Investigational Site
  • Washington
    • Tacoma, Washington, United States, 98431-5000
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
• Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
• Patients with a baseline pain intensity (categorical) of moderate or severe

Exclusion Criteria:

• Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
• Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
• Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
• Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
• Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: valdecoxib; valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5; Drug: valdecoxib; valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth twice daily on Days 2 through 5
Active Comparator: Arm 1	Drug: valdecoxib; valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5; Drug: valdecoxib; valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth twice daily on Days 2 through 5
Active Comparator: Arm 3	Drug: valdecoxib/placebo; valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then placebo on Days 2 through 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient's Global Evaluation of Study Medication	Day 2 and Day 3
Summed Pain Intensity (SPI) (categorical) through 24 hours	Day 2 and Day 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient's Global Evaluation of Study Medication	Day 4 and Day 5
SPI 24 (categorical)	Day 4 and Day 5
Health Outcomes Post-Discharge Recovery Experience	Days 2 to 5
adverse events	continuous
Time to first dose of rescue medication (rescue analgesic medication)	Days 2 to 5
Time-specific Pain Intensity (PI) (categorical)	Days 2 to 5
SPI 24 (Visual Analog Scale [VAS])	Days 2 to 5
Time-specific PI (VAS)	Days 2 to 5
Percent of patients who took rescue medication (rescue analgesic medication)	Days 2 to 5
Worst Pain Intensity (derived from the Modified BPI-Short Form)	Days 2 to 5
Time between doses of study medication	Days 2 to 5
Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form)	Days 2 to 5
Symptom Distress Questionnaire	Days 2 to 5
Average Pain Intensity (derived from the Modified BPI-Short Form)	Days 2 to 5
Amount of rescue medication (rescue analgesic medication) taken	Days 2 to 5

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Study Completion (Actual): February 1, 2003

Study Registration Dates

• First Submitted: March 31, 2008
• First Submitted That Met QC Criteria: May 22, 2008
• First Posted (Estimate): May 23, 2008

Study Record Updates

• Last Update Posted (Estimate): May 23, 2008
• Last Update Submitted That Met QC Criteria: May 22, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Foot Deformities; Pain, Postoperative; Hallux Valgus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Valdecoxib
• Other Study ID Numbers: VALA-0513-144; A3471084