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

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ClinicalTrials.gov Identifier: NCT00683137
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : May 23, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 31, 2008
First Posted Date  ICMJE May 23, 2008
Last Update Posted Date May 23, 2008
Study Start Date  ICMJE October 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2008)
  • Patient's Global Evaluation of Study Medication [ Time Frame: Day 2 and Day 3 ]
  • Summed Pain Intensity (SPI) (categorical) through 24 hours [ Time Frame: Day 2 and Day 3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2008)
  • Health Outcomes Post-Discharge Recovery Experience [ Time Frame: Days 2 to 5 ]
  • adverse events [ Time Frame: continuous ]
  • Time to first dose of rescue medication (rescue analgesic medication) [ Time Frame: Days 2 to 5 ]
  • SPI 24 (categorical) [ Time Frame: Day 4 and Day 5 ]
  • Time-specific Pain Intensity (PI) (categorical) [ Time Frame: Days 2 to 5 ]
  • SPI 24 (Visual Analog Scale [VAS]) [ Time Frame: Days 2 to 5 ]
  • Time-specific PI (VAS) [ Time Frame: Days 2 to 5 ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: Day 4 and Day 5 ]
  • Percent of patients who took rescue medication (rescue analgesic medication) [ Time Frame: Days 2 to 5 ]
  • Worst Pain Intensity (derived from the Modified BPI-Short Form) [ Time Frame: Days 2 to 5 ]
  • Time between doses of study medication [ Time Frame: Days 2 to 5 ]
  • Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form) [ Time Frame: Days 2 to 5 ]
  • Symptom Distress Questionnaire [ Time Frame: Days 2 to 5 ]
  • Average Pain Intensity (derived from the Modified BPI-Short Form) [ Time Frame: Days 2 to 5 ]
  • Amount of rescue medication (rescue analgesic medication) taken [ Time Frame: Days 2 to 5 ]
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 And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery
Official Title  ICMJE 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
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.
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
  • Hallux Valgus
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 3
    Intervention: Drug: valdecoxib/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: May 22, 2008)
450
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 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) 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
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 NCT00683137
Other Study ID Numbers  ICMJE VALA-0513-144
A3471084
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 May 2008

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