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Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery
This study has been completed.
First Received: March 31, 2008   Last Updated: May 22, 2008   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00683137
  Purpose

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.


Condition Intervention Phase
Pain
Hallux Valgus
 Drug: valdecoxib
Drug: valdecoxib/placebo
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Surgery
Drug Information available for: Valdecoxib
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Patient's Global Evaluation of Study Medication [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]
  • Summed Pain Intensity (SPI) (categorical) through 24 hours [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health Outcomes Post-Discharge Recovery Experience [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Time to first dose of rescue medication (rescue analgesic medication) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • SPI 24 (categorical) [ Time Frame: Day 4 and Day 5 ] [ Designated as safety issue: No ]
  • Time-specific Pain Intensity (PI) (categorical) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • SPI 24 (Visual Analog Scale [VAS]) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Time-specific PI (VAS) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: Day 4 and Day 5 ] [ Designated as safety issue: No ]
  • Percent of patients who took rescue medication (rescue analgesic medication) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Worst Pain Intensity (derived from the Modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Time between doses of study medication [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Symptom Distress Questionnaire [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Average Pain Intensity (derived from the Modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Amount of rescue medication (rescue analgesic medication) taken [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: October 2002
Study Completion Date: February 2003
Arms Assigned Interventions
Arm 1: Active Comparator 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
Arm 2: Active Comparator 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
Arm 3: Active Comparator 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683137

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: VALA-0513-144, A3471084
Study First Received: March 31, 2008
Last Updated: May 22, 2008
ClinicalTrials.gov Identifier: NCT00683137     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Hallux Valgus
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Musculoskeletal Diseases
Sensory System Agents
 Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Valdecoxib
Foot Deformities
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009



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