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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00636064
First received: March 7, 2008
Last updated: October 9, 2008
Last verified: March 2008
  Purpose

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


Condition Intervention Phase
Pain
Drug: Parecoxib Sodium/Valdecoxib
Drug: Placebo/Valdecoxib
Other: Placebo/Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • Rate of supplemental analgesia consumed [ Time Frame: Days 1-10 ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Opioid-related Symptoms Distress Scale (OR-SDS) [ Time Frame: Days 1-10 ] [ Designated as safety issue: No ]
  • Time to last Patient Controlled Analgesia (PCA) dose [ Designated as safety issue: No ]
  • Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge) [ Designated as 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 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Clinical laboratory assessments [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Peak Pain Intensity (PPI) of sternotomy alone and overall body pain [ Time Frame: Days 1-10 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory-short form (mBPI-sf) [ Time Frame: Days 1-10 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment: 1671
Study Start Date: January 2003
Study Completion Date: January 2004
Arms Assigned Interventions
Placebo Comparator: A 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.
Experimental: B 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.
Experimental: C 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636064

  Show 207 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00636064     History of Changes
Other Study ID Numbers: PARA-0505-071, A3481015
Study First Received: March 7, 2008
Last Updated: October 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parecoxib
Valdecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014