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Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

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ClinicalTrials.gov Identifier: NCT00653354
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : December 5, 2018
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 1, 2008
First Posted Date  ICMJE April 4, 2008
Last Update Posted Date December 5, 2018
Study Start Date  ICMJE December 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
  • Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24) [ Time Frame: Day 1 ]
  • Total Pain Relief through 24 hours (TOTPAR 24) [ Time Frame: Day 1 ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: Day 1 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
  • time between doses of study medication [ Time Frame: Day 1 ]
  • Time-specific Pain Intensity Difference (PID) (categorical) [ Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours ]
  • time-specific pain relief [ Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours ]
  • time-specific PID (VAS) [ Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours ]
  • Summed Pain Intensity (SPID)24 (VAS) [ Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours ]
  • time to rescue medication [ Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours ]
  • percent of patients who took rescue medication [ Time Frame: Day 1 ]
  • Patient's Satisfaction Questionnaire [ Time Frame: Day 1 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain, Post-surgical
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: valdecoxib/placebo
  • Placebo Comparator: Arm 3
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2008)
360
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00653354
Other Study ID Numbers  ICMJE VALA-0513-149
A3471086
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP