Official Title: “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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Parecoxib 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.
• Drug: Placebo/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.
• Other: Placebo/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.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
• Experimental: B
• Experimental: C

Primary Measures

• Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE)
  • Time Frame: Day 30
    Safety Issue?: No

Secondary Measures

• 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
  • Time Frame: Day 30
    Safety Issue?: No
• Rate of supplemental analgesia consumed
  • Time Frame: Days 1-10
    Safety Issue?: No
• Vital signs
  • Time Frame: Day 30
    Safety Issue?: No
• Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8)
  • Time Frame: Day 1
    Safety Issue?: No
• Opioid-related Symptoms Distress Scale (OR-SDS)
  • Time Frame: Days 1-10
    Safety Issue?: No
• Time to last Patient Controlled Analgesia (PCA) dose
  • Safety Issue?: No
• Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge)
  • Safety Issue?: No
• 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
  • Time Frame: Day 30
    Safety Issue?: No
• Adverse events
  • Time Frame: Day 30
    Safety Issue?: No
• Serious adverse events
  • Time Frame: Day 30
    Safety Issue?: No
• Clinical laboratory assessments
  • Time Frame: Day 30
    Safety Issue?: No
• Peak Pain Intensity (PPI) of sternotomy alone and overall body pain
  • Time Frame: Days 1-10
    Safety Issue?: No
• Patient's and Physician's Global Evaluation of Study Medication
  • Time Frame: At time of transition from intravenous to oral medication and final visit/early termination
    Safety Issue?: No
• Modified Brief Pain Inventory-short form (mBPI-sf)
  • Time Frame: Days 1-10
    Safety Issue?: No
• SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24)
  • Time Frame: Days 1-10
    Safety Issue?: No

Inclusion Criteria:

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:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00636064

Study ID Number: PARA-0505-071

ClinicalTrials.gov Identifier: NCT00636064

Health Authority: United States: Food and Drug Administration

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