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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00683137
Collaborator
(none)
450
Enrollment
90
Locations
3
Arms
4
Duration (Months)
5
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2002
Actual Study Completion Date :
Feb 1, 2003

Arms and Interventions

Arm Intervention/Treatment
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
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 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

Outcome Measures

Primary Outcome Measures

  1. Patient's Global Evaluation of Study Medication [Day 2 and Day 3]

  2. Summed Pain Intensity (SPI) (categorical) through 24 hours [Day 2 and Day 3]

Secondary Outcome Measures

  1. Health Outcomes Post-Discharge Recovery Experience [Days 2 to 5]

  2. adverse events [continuous]

  3. Time to first dose of rescue medication (rescue analgesic medication) [Days 2 to 5]

  4. SPI 24 (categorical) [Day 4 and Day 5]

  5. Time-specific Pain Intensity (PI) (categorical) [Days 2 to 5]

  6. SPI 24 (Visual Analog Scale [VAS]) [Days 2 to 5]

  7. Time-specific PI (VAS) [Days 2 to 5]

  8. Patient's Global Evaluation of Study Medication [Day 4 and Day 5]

  9. Percent of patients who took rescue medication (rescue analgesic medication) [Days 2 to 5]

  10. Worst Pain Intensity (derived from the Modified BPI-Short Form) [Days 2 to 5]

  11. Time between doses of study medication [Days 2 to 5]

  12. Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form) [Days 2 to 5]

  13. Symptom Distress Questionnaire [Days 2 to 5]

  14. Average Pain Intensity (derived from the Modified BPI-Short Form) [Days 2 to 5]

  15. Amount of rescue medication (rescue analgesic medication) taken [Days 2 to 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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) 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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Chandler Arizona United States 85224
2 Pfizer Investigational Site Glendale Arizona United States 85302
3 Pfizer Investigational Site Glendale Arizona United States 85306
4 Pfizer Investigational Site Mesa Arizona United States 85204
5 Pfizer Investigational Site Phoenix Arizona United States 58029
6 Pfizer Investigational Site Phoenix Arizona United States 85012
7 Pfizer Investigational Site Phoenix Arizona United States 85015
8 Pfizer Investigational Site Phoenix Arizona United States 85016
9 Pfizer Investigational Site Phoenix Arizona United States 85022
10 Pfizer Investigational Site Phoenix Arizona United States 85023
11 Pfizer Investigational Site National City California United States 91950
12 Pfizer Investigational Site San Diego California United States 91950
13 Pfizer Investigational Site San Diego California United States 92103
14 Pfizer Investigational Site San Diego California United States 92114
15 Pfizer Investigational Site San Diego California United States 92116
16 Pfizer Investigational Site Milford Connecticut United States 06460
17 Pfizer Investigational Site New Haven Connecticut United States 06515
18 Pfizer Investigational Site New Haven Connecticut United States 6515
19 Pfizer Investigational Site Cooper City Florida United States 33330
20 Pfizer Investigational Site Cutler Ridge Florida United States 33157
21 Pfizer Investigational Site Fort Lauderdale Florida United States 33308
22 Pfizer Investigational Site Ft. Lauderdale Florida United States 33306
23 Pfizer Investigational Site Ft. Lauderdale Florida United States 33308
24 Pfizer Investigational Site Hallandale Florida United States 33009
25 Pfizer Investigational Site Hollywood Florida United States 33020
26 Pfizer Investigational Site Hollywood Florida United States 33021
27 Pfizer Investigational Site Miami Florida United States 33180
28 Pfizer Investigational Site New Port Richey Florida United States 34652
29 Pfizer Investigational Site New Port Richey Florida United States 34653
30 Pfizer Investigational Site New Port Richey Florida United States 34655
31 Pfizer Investigational Site Pembroke Pines Florida United States 33027
32 Pfizer Investigational Site Pembroke Pines Florida United States 33028
33 Pfizer Investigational Site Port Richey Florida United States 34668
34 Pfizer Investigational Site South Miami Florida United States 33143
35 Pfizer Investigational Site Spring Hill Florida United States 34608
36 Pfizer Investigational Site Addison Illinois United States 60101
37 Pfizer Investigational Site Elk Grove Village Illinois United States 60007
38 Pfizer Investigational Site Peoria Illinois United States 61602
39 Pfizer Investigational Site Peoria Illinois United States 61614
40 Pfizer Investigational Site Peoria Illinois United States 61615
41 Pfizer Investigational Site Evansville Indiana United States 47713
42 Pfizer Investigational Site New Orleans Louisiana United States 70127
43 Pfizer Investigational Site New Orleans Louisiana United States 70128
44 Pfizer Investigational Site Annapolis Maryland United States 21401
45 Pfizer Investigational Site Chester Maryland United States 21619
46 Pfizer Investigational Site Omaha Nebraska United States 68124
47 Pfizer Investigational Site Omaha Nebraska United States 68134
48 Pfizer Investigational Site Omaha Nebraska United States 68144
49 Pfizer Investigational Site Las Vegas Nevada United States 89102
50 Pfizer Investigational Site Las Vegas Nevada United States 89104
51 Pfizer Investigational Site Las Vegas Nevada United States 89106
52 Pfizer Investigational Site Las Vegas Nevada United States 89121
53 Pfizer Investigational Site Las Vegas Nevada United States 89128
54 Pfizer Investigational Site Bismarck North Dakota United States 58501
55 Pfizer Investigational Site Austintown Ohio United States 44515
56 Pfizer Investigational Site Canfield Ohio United States 44406
57 Pfizer Investigational Site Cleveland Ohio United States 44106
58 Pfizer Investigational Site Youngstown Ohio United States 44512
59 Pfizer Investigational Site Youngstown Ohio United States 44515
60 Pfizer Investigational Site Portland Oregon United States 97205
61 Pfizer Investigational Site Altoona Pennsylvania United States 16602
62 Pfizer Investigational Site Altoona Pennsylvania United States
63 Pfizer Investigational Site Duncansville Pennsylvania United States 16635
64 Pfizer Investigational Site Havertown Pennsylvania United States 19083
65 Pfizer Investigational Site Media Pennsylvania United States 19063
66 Pfizer Investigational Site Philadelphia Pennsylvania United States 19107-2496
67 Pfizer Investigational Site Philadelphia Pennsylvania United States 19140
68 Pfizer Investigational Site Philadelphia Pennsylvania United States
69 Pfizer Investigational Site Reading Pennsylvania United States 19606
70 Pfizer Investigational Site State College Pennsylvania United States 16803
71 Pfizer Investigational Site Upland Pennsylvania United States 19013
72 Pfizer Investigational Site Wyomissig Pennsylvania United States 19610
73 Pfizer Investigational Site Greer South Carolina United States 29651
74 Pfizer Investigational Site Austin Texas United States 78731
75 Pfizer Investigational Site Austin Texas United States 78756
76 Pfizer Investigational Site San Antonio Texas United States 78205
77 Pfizer Investigational Site San Antonio Texas United States 78209
78 Pfizer Investigational Site San Antonio Texas United States 78240
79 Pfizer Investigational Site San Antonio Texas United States
80 Pfizer Investigational Site Holladay Utah United States 84117
81 Pfizer Investigational Site Layton Utah United States 84041
82 Pfizer Investigational Site Provo Utah United States 84054
83 Pfizer Investigational Site Salt Lake City Utah United States 84102
84 Pfizer Investigational Site Salt Lake City Utah United States 84107
85 Pfizer Investigational Site Salt Lake City Utah United States 84117
86 Pfizer Investigational Site Salt Lake City Utah United States 84124
87 Pfizer Investigational Site Salt Lake City Utah United States 84157-0667
88 Pfizer Investigational Site Sandy Utah United States 84070
89 Pfizer Investigational Site St. George Utah United States 84770
90 Pfizer Investigational Site Tacoma Washington United States 98431-5000

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00683137
Other Study ID Numbers:
  • VALA-0513-144
  • A3471084
First Posted:
May 23, 2008
Last Update Posted:
May 23, 2008
Last Verified:
May 1, 2008
Additional relevant MeSH terms:
Hallux Valgus
Pain, Postoperative
Valdecoxib

Study Results

No Results Posted as of May 23, 2008