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Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00653354
Collaborator
(none)
360
Enrollment
21
Locations
3
Arms
3
Duration (Months)
17.1
Patients Per Site
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Assessment Of The Analgesic Efficacy Of The Dosing Regimen Of Valdecoxib Compared To Placebo Patients In Pain Following Bunionectomy
Study Start Date :
Dec 1, 2002
Actual Study Completion Date :
Mar 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1

Drug: valdecoxib
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
Active Comparator: Arm 2

Drug: valdecoxib/placebo
valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
Placebo Comparator: Arm 3

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

Outcome Measures

Primary Outcome Measures

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

  2. Total Pain Relief through 24 hours (TOTPAR 24) [Day 1]

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

Secondary Outcome Measures

  1. time between doses of study medication [Day 1]

  2. Time-specific Pain Intensity Difference (PID) (categorical) [0, 2, 4, 6, 8, 10, 12, 16, and 24 hours]

  3. time-specific pain relief [2, 4, 6, 8, 10, 12, 16, and 24 hours]

  4. time-specific PID (VAS) [0, 2, 4, 6, 8, 10, 12, 16, and 24 hours]

  5. Summed Pain Intensity (SPID)24 (VAS) [0, 2, 4, 6, 8, 10, 12, 16, and 24 hours]

  6. time to rescue medication [2, 4, 6, 8, 10, 12, 16, and 24 hours]

  7. percent of patients who took rescue medication [Day 1]

  8. Patient's Satisfaction Questionnaire [Day 1]

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) 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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Phoenix Arizona United States 85015
2 Pfizer Investigational Site Phoenix Arizona United States 85016
3 Pfizer Investigational Site Phoenix Arizona United States 85020
4 Pfizer Investigational Site Phoenix Arizona United States 85032
5 Pfizer Investigational Site Tempe Arizona United States 85281
6 Pfizer Investigational Site Anaheim California United States 92701
7 Pfizer Investigational Site Chula Vista California United States 91911
8 Pfizer Investigational Site San Diego California United States 92114
9 Pfizer Investigational Site Santa Ana California United States 92701
10 Pfizer Investigational Site Tustin California United States 92780
11 Pfizer Investigational Site Lexington Kentucky United States 40504
12 Pfizer Investigational Site Lexington Kentucky United States 40509
13 Pfizer Investigational Site Lexington Kentucky United States 40515
14 Pfizer Investigational Site Altoona Pennsylvania United States 16602
15 Pfizer Investigational Site Duncansville Pennsylvania United States 16635
16 Pfizer Investigational Site Johnson City Tennessee United States 37601
17 Pfizer Investigational Site Johnson City Tennessee United States 37604
18 Pfizer Investigational Site San Antonio Texas United States 78229
19 Pfizer Investigational Site San Antonio Texas United States 78240
20 Pfizer Investigational Site Salt Lake City Utah United States 84117
21 Pfizer Investigational Site Salt Lake City Utah United States 84123

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:
NCT00653354
Other Study ID Numbers:
  • VALA-0513-149
  • A3471086
First Posted:
Apr 4, 2008
Last Update Posted:
Dec 5, 2018
Last Verified:
Dec 1, 2018
Keywords provided by , ,
hallux valgus
Additional relevant MeSH terms:
Pain, Postoperative
Valdecoxib

Study Results

No Results Posted as of Dec 5, 2018