Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00653354
First received: April 1, 2008
Last updated: April 7, 2008
Last verified: April 2008

April 1, 2008
April 7, 2008
December 2002
Not Provided
  • Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Total Pain Relief through 24 hours (TOTPAR 24) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00653354 on ClinicalTrials.gov Archive Site
  • time between doses of study medication [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Time-specific Pain Intensity Difference (PID) (categorical) [ Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
  • time-specific pain relief [ Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
  • time-specific PID (VAS) [ Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
  • Summed Pain Intensity (SPID)24 (VAS) [ Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
  • time to rescue medication [ Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
  • percent of patients who took rescue medication [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Patient's Satisfaction Questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00653354
VALA-0513-149, A3471086
No
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