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

Primary Purpose

Pain, Hallux Valgus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
valdecoxib
valdecoxib
valdecoxib/placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Patient's Global Evaluation of Study Medication
Summed Pain Intensity (SPI) (categorical) through 24 hours

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2008
Last Updated
May 22, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00683137
Brief Title
Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hallux Valgus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Title
Arm 3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
valdecoxib/placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Patient's Global Evaluation of Study Medication
Time Frame
Day 2 and Day 3
Title
Summed Pain Intensity (SPI) (categorical) through 24 hours
Time Frame
Day 2 and Day 3
Secondary Outcome Measure Information:
Title
Health Outcomes Post-Discharge Recovery Experience
Time Frame
Days 2 to 5
Title
adverse events
Time Frame
continuous
Title
Time to first dose of rescue medication (rescue analgesic medication)
Time Frame
Days 2 to 5
Title
SPI 24 (categorical)
Time Frame
Day 4 and Day 5
Title
Time-specific Pain Intensity (PI) (categorical)
Time Frame
Days 2 to 5
Title
SPI 24 (Visual Analog Scale [VAS])
Time Frame
Days 2 to 5
Title
Time-specific PI (VAS)
Time Frame
Days 2 to 5
Title
Patient's Global Evaluation of Study Medication
Time Frame
Day 4 and Day 5
Title
Percent of patients who took rescue medication (rescue analgesic medication)
Time Frame
Days 2 to 5
Title
Worst Pain Intensity (derived from the Modified BPI-Short Form)
Time Frame
Days 2 to 5
Title
Time between doses of study medication
Time Frame
Days 2 to 5
Title
Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form)
Time Frame
Days 2 to 5
Title
Symptom Distress Questionnaire
Time Frame
Days 2 to 5
Title
Average Pain Intensity (derived from the Modified BPI-Short Form)
Time Frame
Days 2 to 5
Title
Amount of rescue medication (rescue analgesic medication) taken
Time Frame
Days 2 to 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85302
Country
United States
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Pfizer Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85204
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
58029
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85022
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Pfizer Investigational Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92116
Country
United States
Facility Name
Pfizer Investigational Site
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06515
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
6515
Country
United States
Facility Name
Pfizer Investigational Site
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33330
Country
United States
Facility Name
Pfizer Investigational Site
City
Cutler Ridge
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Pfizer Investigational Site
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Pfizer Investigational Site
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Pfizer Investigational Site
City
Hallandale
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Pfizer Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Facility Name
Pfizer Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Pfizer Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Pfizer Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Pfizer Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Pfizer Investigational Site
City
Port Richey
State/Province
Florida
ZIP/Postal Code
34668
Country
United States
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34608
Country
United States
Facility Name
Pfizer Investigational Site
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
Pfizer Investigational Site
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Pfizer Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Pfizer Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Pfizer Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Pfizer Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70127
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70128
Country
United States
Facility Name
Pfizer Investigational Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Pfizer Investigational Site
City
Chester
State/Province
Maryland
ZIP/Postal Code
21619
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Pfizer Investigational Site
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Pfizer Investigational Site
City
Austintown
State/Province
Ohio
ZIP/Postal Code
44515
Country
United States
Facility Name
Pfizer Investigational Site
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pfizer Investigational Site
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Pfizer Investigational Site
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44515
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
Country
United States
Facility Name
Pfizer Investigational Site
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Pfizer Investigational Site
City
Altoona
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pfizer Investigational Site
City
Havertown
State/Province
Pennsylvania
ZIP/Postal Code
19083
Country
United States
Facility Name
Pfizer Investigational Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-2496
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States
Facility Name
Pfizer Investigational Site
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
Pfizer Investigational Site
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Pfizer Investigational Site
City
Wyomissig
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Pfizer Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Holladay
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Pfizer Investigational Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Pfizer Investigational Site
City
Provo
State/Province
Utah
ZIP/Postal Code
84054
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84157-0667
Country
United States
Facility Name
Pfizer Investigational Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Pfizer Investigational Site
City
St. George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Pfizer Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-5000
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=VALA-0513-144&StudyName=Analgesic%20Efficacy%20And%20Safety%20of%20Valdecoxib%20For%20Treatment%20Of%20Post-Surgical%20Pain%20From%20Bunionectomy%20Surgery.%0A
Description
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Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

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