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Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85015 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Post-Surgical Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00653354
Pfizer
Completed
Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

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Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pain, Post-Surgical
  • 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
  • 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
  • Drug: placebo
    placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: valdecoxib/placebo
  • Placebo Comparator: Arm 3
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
March 2003
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00653354
VALA-0513-149
A3471086
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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