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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Parecoxib Sodium/Valdecoxib; Drug: Placebo/Valdecoxib; Other: Placebo/Placebo

• Study Type: Interventional
• Enrollment (Actual): 1671
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1118
    • Pfizer Investigational Site
  • Buenos Aires, Argentina, 1416
    • Pfizer Investigational Site
  • Buenos Aires, Argentina, C1405DCS
    • Pfizer Investigational Site
  • Pcia. de Buenos Aires
    • Morón, Pcia. de Buenos Aires, Argentina, 1708
      • Pfizer Investigational Site
• Australia
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Pfizer Investigational Site
  • South Australia
    • Ashford, South Australia, Australia, 5035
      • Pfizer Investigational Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Pfizer Investigational Site
• Austria
  • Graz, Austria, 8036
    • Pfizer Investigational Site
• Belgium
  • Brussel, Belgium, 1090
    • Pfizer Investigational Site
  • Bruxelles, Belgium, 1070
    • Pfizer Investigational Site
  • Edegem, Belgium, 2650
    • Pfizer Investigational Site
  • Genk, Belgium, 3600
    • Pfizer Investigational Site
  • Liege, Belgium, B-4000
    • Pfizer Investigational Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Pfizer Investigational Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Pfizer Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Pfizer Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Pfizer Investigational Site
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Pfizer Investigational Site
    • Kingston, Ontario, Canada, K7L 5G2
      • Pfizer Investigational Site
    • London, Ontario, Canada, N6A 5A5
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5G 2C4
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Pfizer Investigational Site
  • Quebec
    • Fleurimont, Quebec, Canada, J1H 5N4
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3A 1A1
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H1T 1C8
      • Pfizer Investigational Site
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • Pfizer Investigational Site
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Pfizer Investigational Site
• Colombia
  • Bogota, Colombia
    • Pfizer Investigational Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 000
      • Pfizer Investigational Site
  • Santander
    • Floridablanca, Santander, Colombia, 000
      • Pfizer Investigational Site
  • Valle
    • Cali, Valle, Colombia, Nap
      • Pfizer Investigational Site
• Czech Republic
  • Ceske Budejovice, Czech Republic, 370 87
    • Pfizer Investigational Site
  • Prague, Czech Republic, 100 34
    • Pfizer Investigational Site
  • Prague, Czech Republic, 128 00
    • Pfizer Investigational Site
  • Prague, Czech Republic, 14220
    • Pfizer Investigational Site
  • Prague, Czech Republic, 150 00
    • Pfizer Investigational Site
  • Prague 5, Czech Republic, 15500
    • Pfizer Investigational Site
• Denmark
  • Kobenhavn, Denmark, 2100
    • Pfizer Investigational Site
  • Odense C, Denmark, 5000
    • Pfizer Investigational Site
• Finland
  • Kuopio, Finland
    • Pfizer Investigational Site
  • Kuopio, Finland, 70211
    • Pfizer Investigational Site
  • Oulu, Finland
    • Pfizer Investigational Site
  • Turku, Finland, FIN-20520
    • Pfizer Investigational Site
• Germany
  • Aachen, Germany, 52074
    • Pfizer Investigational Site
  • Bonn, Germany, 53105
    • Pfizer Investigational Site
  • Giessen, Germany, 35385
    • Pfizer Investigational Site
  • Goettingen, Germany, 37075
    • Pfizer Investigational Site
  • Hamburg, Germany, 20251
    • Pfizer Investigational Site
  • Heidelberg, Germany, 69120
    • Pfizer Investigational Site
  • Kassel, Germany, 34125
    • Pfizer Investigational Site
  • Kiel, Germany, 24105
    • Pfizer Investigational Site
  • Muenchen, Germany, 81377
    • Pfizer Investigational Site
  • Muenster, Germany, 48149
    • Pfizer Investigational Site
• Ireland
  • Dublin, Ireland
    • Pfizer Investigational Site
• Israel
  • Beer Sheva, Israel
    • Pfizer Investigational Site
  • Haifa, Israel
    • Pfizer Investigational Site
  • Haifa, Israel, 34362
    • Pfizer Investigational Site
  • Holon, Israel, 58100
    • Pfizer Investigational Site
  • Jerusalem, Israel, 91120
    • Pfizer Investigational Site
  • Jerusalem, Israel, 91031
    • Pfizer Investigational Site
  • Jerusalem, Israel, 91004
    • Pfizer Investigational Site
  • Petach-Tikva, Israel, 49261
    • Pfizer Investigational Site
  • Ramat-Gan, Israel
    • Pfizer Investigational Site
  • Rehovot, Israel
    • Pfizer Investigational Site
  • Tel Aviv, Israel
    • Pfizer Investigational Site
  • Tel Hashomer, Israel, 52651
    • Pfizer Investigational Site
• Italy
  • Firenze, Italy, 50134
    • Pfizer Investigational Site
  • Milano, Italy, 20138
    • Pfizer Investigational Site
  • Pavia, Italy, 27100
    • Pfizer Investigational Site
  • Pisa, Italy, 56125
    • Pfizer Investigational Site
• Mexico
  • DF
    • Mexico City, DF, Mexico, 03100
      • Pfizer Investigational Site
    • Mexico City, DF, Mexico, 06720
      • Pfizer Investigational Site
    • Mexico City, DF, Mexico, 14050
      • Pfizer Investigational Site
  • Mexico DF
    • Mexico City, Mexico DF, Mexico, 07760
      • Pfizer Investigational Site
  • Mexico, DF
    • Mexico City, Mexico, DF, Mexico, 14000
      • Pfizer Investigational Site
• Netherlands
  • Breda, Netherlands, 4836 AE
    • Pfizer Investigational Site
  • Eindhoven, Netherlands, 5623 EJ
    • Pfizer Investigational Site
  • Zwolle, Netherlands, 8011 JW
    • Pfizer Investigational Site
• Norway
  • Feiring, Norway, 2093
    • Pfizer Investigational Site
• Poland
  • Bialystok, Poland, 15-276
    • Pfizer Investigational Site
  • Krakow, Poland, 31-202
    • Pfizer Investigational Site
  • Poznan, Poland, 61-848
    • Pfizer Investigational Site
  • Szczecin, Poland, 70-111
    • Pfizer Investigational Site
  • Warszawa, Poland, 02-097
    • Pfizer Investigational Site
• Romania
  • Bucharest, Romania, 7000
    • Pfizer Investigational Site
  • Bucharest, Romania, 771181
    • Pfizer Investigational Site
  • Bucuresti, Romania, 7000
    • Pfizer Investigational Site
  • Bucuresti, Romania, 71406
    • Pfizer Investigational Site
  • Cluj-Napoca, Romania, 3400
    • Pfizer Investigational Site
  • Timisoara, Romania, 1900
    • Pfizer Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 119992
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 123182
    • Pfizer Investigational Site
• Singapore
  • Singapore, Singapore, 168752
    • Pfizer Investigational Site
• Slovakia
  • Bratislava, Slovakia, 833 48
    • Pfizer Investigational Site
  • Kosice, Slovakia, 040-11
    • Pfizer Investigational Site
• South Africa
  • Bloemfontein, South Africa, 9300
    • Pfizer Investigational Site
  • Pretoria, South Africa, 0002
    • Pfizer Investigational Site
  • Pretoria, South Africa, 0040
    • Pfizer Investigational Site
  • Free State
    • Bloemfontein, Free State, South Africa
      • Pfizer Investigational Site
  • Gauteng
    • Pretoria, Gauteng, South Africa
      • Pfizer Investigational Site
    • Pretoria, Gauteng, South Africa, 0002
      • Pfizer Investigational Site
    • Pretoria, Gauteng, South Africa, 0084
      • Pfizer Investigational Site
  • Gauteng Province
    • Johannesburg, Gauteng Province, South Africa
      • Pfizer Investigational Site
    • Pretoria, Gauteng Province, South Africa, 0140
      • Pfizer Investigational Site
  • KwaZulu Natal
    • Durban, KwaZulu Natal, South Africa
      • Pfizer Investigational Site
  • Pretoria
    • Les Marais, Pretoria, South Africa, 0084
      • Pfizer Investigational Site
  • Western Cape
    • Parow, Western Cape, South Africa, 7500
      • Pfizer Investigational Site
• Spain
  • Barcelona, Spain, 08025
    • Pfizer Investigational Site
  • Barcelona, Spain, 08907
    • Pfizer Investigational Site
  • Madrid, Spain, 28046
    • Pfizer Investigational Site
  • Valencia, Spain, 46010
    • Pfizer Investigational Site
• Sweden
  • Orebro, Sweden, SE-701 85
    • Pfizer Investigational Site
  • Stockholm, Sweden, 171 76
    • Pfizer Investigational Site
  • Uppsala, Sweden, SE 751 85
    • Pfizer Investigational Site
• Switzerland
  • Bern, Switzerland, 3010
    • Pfizer Investigational Site
  • Geneve 14, Switzerland, 1211
    • Pfizer Investigational Site
• United Kingdom
  • Edinburgh, United Kingdom, Eh3 9YW
    • Pfizer Investigational Site
  • Liverpool, United Kingdom
    • Pfizer Investigational Site
  • London, United Kingdom, SE1 7EH
    • Pfizer Investigational Site
  • London, United Kingdom, E2 9JX
    • Pfizer Investigational Site
  • Middlesbrough, United Kingdom, TS4 3BW
    • Pfizer Investigational Site
  • Oxford, United Kingdom, OX3 9DU
    • Pfizer Investigational Site
• United States
  • Alabama
    • Fairhope, Alabama, United States, 36532
      • Pfizer Investigational Site
    • Mobile, Alabama, United States, 36608
      • Pfizer Investigational Site
    • Mobile, Alabama, United States, 36604
      • Pfizer Investigational Site
    • Mobile, Alabama, United States, 36607
      • Pfizer Investigational Site
    • Mobile, Alabama, United States, 36602
      • Pfizer Investigational Site
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Pfizer Investigational Site
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Pfizer Investigational Site
    • Springdale, Arkansas, United States, 72764
      • Pfizer Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Pfizer Investigational Site
    • Anaheim, California, United States, 92805
      • Pfizer Investigational Site
    • Los Angeles, California, United States, 90033
      • Pfizer Investigational Site
    • Los Angeles, California, United States, 90095-1778
      • Pfizer Investigational Site
    • Orange, California, United States, 92868
      • Pfizer Investigational Site
    • Sacramento, California, United States, 95825
      • Pfizer Investigational Site
    • Sacramento, California, United States, 95819
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94115
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94118-3110
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94143-0648
      • Pfizer Investigational Site
    • Santa Rosa, California, United States, 95403
      • Pfizer Investigational Site
    • Santa Rosa, California, United States, 95404
      • Pfizer Investigational Site
    • Stanford, California, United States, 94305
      • Pfizer Investigational Site
  • Colorado
    • Fort Collins, Colorado, United States, 80524
      • Pfizer Investigational Site
    • Fort Collins, Colorado, United States, 80528
      • Pfizer Investigational Site
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Pfizer Investigational Site
    • New Haven, Connecticut, United States, 06504
      • Pfizer Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Pfizer Investigational Site
  • Florida
    • Brandon, Florida, United States, 33511
      • Pfizer Investigational Site
    • Clearwater, Florida, United States, 33756
      • Pfizer Investigational Site
    • Hudson, Florida, United States, 34667
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Pfizer Investigational Site
    • Melbourne, Florida, United States, 32901
      • Pfizer Investigational Site
    • Melbourne, Florida, United States, 32901-3276
      • Pfizer Investigational Site
    • Pensacola, Florida, United States, 32504
      • Pfizer Investigational Site
    • Pensacola, Florida, United States, 32514
      • Pfizer Investigational Site
    • Sarasota, Florida, United States, 34239
      • Pfizer Investigational Site
    • St. Petersburg, Florida, United States, 33709
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33613
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Pfizer Investigational Site
    • Augusta, Georgia, United States, 30901
      • Pfizer Investigational Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Pfizer Investigational Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Pfizer Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Pfizer Investigational Site
    • Salisbury, Maryland, United States, 21801
      • Pfizer Investigational Site
    • Takoma Park, Maryland, United States, 20912
      • Pfizer Investigational Site
    • Towson, Maryland, United States, 21204
      • Pfizer Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Pfizer Investigational Site
    • Cambridge, Massachusetts, United States, 02138
      • Pfizer Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Pfizer Investigational Site
    • Livonia, Michigan, United States, 48150
      • Pfizer Investigational Site
    • Muskegon, Michigan, United States, 49444
      • Pfizer Investigational Site
    • Royal Oak, Michigan, United States, 48073
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10029
      • Pfizer Investigational Site
    • Rochester, New York, United States, 14621
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45236
      • Pfizer Investigational Site
    • Dayton, Ohio, United States, 45408
      • Pfizer Investigational Site
    • Dayton, Ohio, United States, 45414
      • Pfizer Investigational Site
    • Sandusky, Ohio, United States, 44870
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74104
      • Pfizer Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Pfizer Investigational Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16601
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15212
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15224
      • Pfizer Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Pfizer Investigational Site
    • Charleston, South Carolina, United States, 29406
      • Pfizer Investigational Site
    • Charleston, South Carolina, United States, 29401
      • Pfizer Investigational Site
    • Charleston, South Carolina, United States, 29424
      • Pfizer Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Pfizer Investigational Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76107
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76107-2699
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77030
      • Pfizer Investigational Site
    • Irving, Texas, United States, 75061
      • Pfizer Investigational Site
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Pfizer Investigational Site
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Pfizer Investigational Site
    • Falls Church, Virginia, United States, 22042
      • Pfizer Investigational Site
    • Fredericksburg, Virginia, United States, 22401
      • Pfizer Investigational Site
    • Norfolk, Virginia, United States, 23507
      • Pfizer Investigational Site
  • Washington
    • Tacoma, Washington, United States, 98405
      • Pfizer Investigational Site
  • Wisconsin
    • Elkhorn, Wisconsin, United States, 53121
      • Pfizer Investigational Site
    • Madison, Wisconsin, United States, 53792
      • Pfizer Investigational Site
    • Milwaukee, Wisconsin, United States, 53215
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Adverse events	Day 30
Vital signs	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
Rate of supplemental analgesia consumed	Days 1-10
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Study Completion (Actual): January 1, 2004

Study Registration Dates

• First Submitted: March 7, 2008
• First Submitted That Met QC Criteria: March 7, 2008
• First Posted (Estimate): March 14, 2008

Study Record Updates

• Last Update Posted (Estimate): October 10, 2008
• Last Update Submitted That Met QC Criteria: October 9, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Valdecoxib; Parecoxib
• Other Study ID Numbers: PARA-0505-071; A3481015