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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Hallux Valgus

Intervention / Treatment
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* Drug: valdecoxib
* Drug: valdecoxib
* Drug: valdecoxib/placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: valdecoxib<br>* 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<br>|
| Active Comparator: Arm 2<br> | Drug: valdecoxib<br>* 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<br>|
| Active Comparator: Arm 3<br> | Drug: valdecoxib/placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| SPI 24 (categorical) |  | Day 4 and Day 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 |