A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass surgery

Official Title
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A Double-Blind Multicenter Study of the Safety and Efficacy of Parecoxib Sodium/Valdecoxib and Placebo/Valdecoxib Compared to Placebo for Treatment of Post-Surgical Pain in Patients Who Have Coronary Bypass Graft Via Median Sternotomy

Conditions
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Pain

Intervention / Treatment
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* Drug: Parecoxib Sodium/Valdecoxib
* Drug: Placebo/Valdecoxib
* Other: Placebo/Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients expected to receive in-hospital pain medication for pain after coronary artery bypass graft surgery for at least 3 full days and pain medication over a 10-day period New York Heart Association Class I to III or cardiac ejection fraction of at least 35% before surgery Body mass index of less than or equal to 40 kg/m2 and weight of >55 kg Patients scheduled to undergo an isolated (bypass grafting only without valve replacement, significant aortic reconstruction, or ventriculoplasty) primary CABG surgery via median sternotomy, using cardiopulmonary bypass Exclusion criteria: Patient has undergone or is going to have emergency coronary artery bypass graft surgery or surgery without cardiopulmonary bypass procedure Symptomatic peripheral vascular disease Heart attack within 48 hours of surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Parecoxib Sodium/Valdecoxib<br>* Parecoxib sodium 40 mg intravenous (IV) on the day after surgery (Day 1) following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received parecoxib 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV parecoxib sodium, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.<br>|
| Experimental: B<br> | Drug: Placebo/Valdecoxib<br>* Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.<br>|
| Experimental: C<br> | Other: Placebo/Placebo<br>* Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral placebo matched to valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE) |  | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined incidence of the number of patients with at least 1 reported CRAE and the combined incidence of the number of patients with specific reported CRAEs summarized according to the categories listed above |  | Day 30 | 
| Rate of supplemental analgesia consumed |  | Days 1-10 | 
| Vital signs |  | Day 30 | 
| Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8) |  | Day 1 | 
| Opioid-related Symptoms Distress Scale (OR-SDS) |  | Days 1-10 | 
| Time to last Patient Controlled Analgesia (PCA) dose |  |  | 
| Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge) |  |  | 
| Combined incidence of the number of patients with specific confirmed CRAEs in categories of cardiovascular thromboembolic CRAEs, renal CRAEs, upper gastrointestinal ulcer CRAEs, and wound healing complication CRAEs |  | Day 30 | 
| Adverse events |  | Day 30 | 
| Serious adverse events |  | Day 30 | 
| Clinical laboratory assessments |  | Day 30 | 
| Peak Pain Intensity (PPI) of sternotomy alone and overall body pain |  | Days 1-10 | 
| Patient's and Physician's Global Evaluation of Study Medication |  | At time of transition from intravenous to oral medication and final visit/early termination | 
| Modified Brief Pain Inventory-short form (mBPI-sf) |  | Days 1-10 | 
| SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24) |  | Days 1-10 |