Pain
Conditions
Brief summary
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
Interventions
DRUGParecoxib Sodium/Valdecoxib
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.
DRUGPlacebo/Valdecoxib
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.
OTHERPlacebo/Placebo
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.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE) | Day 30 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Adverse events | Day 30 |
Countries
Argentina, Australia, Austria, Belgium, Canada, Colombia, Czechia, Denmark, Finland, Germany, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed