We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683137
First Posted: May 23, 2008
Last Update Posted: May 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention Phase
Pain Hallux Valgus Drug: valdecoxib Drug: valdecoxib/placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 450
Study Start Date: October 2002
Study Completion Date: February 2003
Arms Assigned Interventions
Active Comparator: Arm 1 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
Active Comparator: Arm 2 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
Active Comparator: Arm 3 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683137


  Show 90 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00683137     History of Changes
Other Study ID Numbers: VALA-0513-144
A3471084
First Submitted: March 31, 2008
First Posted: May 23, 2008
Last Update Posted: May 23, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Analgesics
Valdecoxib
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents