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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.
Study NCT00636064   Information provided by Pfizer
First Received: March 7, 2008   Last Updated: October 9, 2008   History of Changes

March 7, 2008
October 9, 2008
January 2003
 
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 ]
Same as current
Complete list of historical versions of study NCT00636064 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
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
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

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Pain
  • Drug: Parecoxib Sodium/Valdecoxib
  • Drug: Placebo/Valdecoxib
  • Other: Placebo/Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1671
January 2004
 

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Canada,   Colombia,   Czech Republic,   Denmark,   Finland,   Germany,   Ireland,   Israel,   Italy,   Mexico,   Netherlands,   Norway,   Poland,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT00636064
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
PARA-0505-071, A3481015
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP