Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

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

Tracking Information

• First Submitted Date: April 1, 2008
• First Posted Date: April 4, 2008
• Last Update Posted Date: December 5, 2018
• Study Start Date: December 2002
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Pain, Post-surgical

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 3, 2008): 360
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2003
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00653354
• Other Study ID Numbers: VALA-0513-149; A3471086
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2018