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

Phase 3

Completed

• Conditions: Pain; Hallux Valgus
• Interventions: Drug: valdecoxib; Drug: valdecoxib/placebo

• Registration Number: NCT00683137
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2002-10
• Study Completion: 2003-02
• Study First Submitted: 2008-03-31
• Status Verified: 2008-05
• Study First Submitted QC: 2008-05-22
• Last Update Submitted: 2008-05-22
• Study First Posted: 2008-05-23
• Last Update Posted: 2008-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	valdecoxib	-
Arm 3	valdecoxib/placebo	-
Arm 2	valdecoxib	-

Primary Outcome Measures

Name	Time	Method
Patient's Global Evaluation of Study Medication	Day 2 and Day 3
Summed Pain Intensity (SPI) (categorical) through 24 hours	Day 2 and Day 3

Secondary Outcome Measures

Name	Time	Method
SPI 24 (categorical)	Day 4 and Day 5
Health Outcomes Post-Discharge Recovery Experience	Days 2 to 5
adverse events	continuous
Time to first dose of rescue medication (rescue analgesic medication)	Days 2 to 5
Time-specific Pain Intensity (PI) (categorical)	Days 2 to 5
SPI 24 (Visual Analog Scale [VAS])	Days 2 to 5
Time-specific PI (VAS)	Days 2 to 5
Patient's Global Evaluation of Study Medication	Day 4 and Day 5
Percent of patients who took rescue medication (rescue analgesic medication)	Days 2 to 5
Worst Pain Intensity (derived from the Modified BPI-Short Form)	Days 2 to 5
Time between doses of study medication	Days 2 to 5
Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form)	Days 2 to 5
Symptom Distress Questionnaire	Days 2 to 5
Average Pain Intensity (derived from the Modified BPI-Short Form)	Days 2 to 5
Amount of rescue medication (rescue analgesic medication) taken	Days 2 to 5

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Tacoma, Washington, United States