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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00683137
First received: March 31, 2008
Last updated: May 22, 2008
Last verified: May 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Summed Pain Intensity (SPI) (categorical) through 24 hours [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health Outcomes Post-Discharge Recovery Experience [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Time to first dose of rescue medication (rescue analgesic medication) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • SPI 24 (categorical) [ Time Frame: Day 4 and Day 5 ] [ Designated as safety issue: No ]
  • Time-specific Pain Intensity (PI) (categorical) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • SPI 24 (Visual Analog Scale [VAS]) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Time-specific PI (VAS) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: Day 4 and Day 5 ] [ Designated as safety issue: No ]
  • Percent of patients who took rescue medication (rescue analgesic medication) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Worst Pain Intensity (derived from the Modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Time between doses of study medication [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Symptom Distress Questionnaire [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Average Pain Intensity (derived from the Modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
  • Amount of rescue medication (rescue analgesic medication) taken [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683137

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00683137     History of Changes
Other Study ID Numbers: VALA-0513-144, A3471084
Study First Received: March 31, 2008
Last Updated: May 22, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Analgesics
Valdecoxib
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on July 23, 2014