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
NCT ID: NCT00636064
Last Updated: 2008-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1671 participants
INTERVENTIONAL
2003-01-31
2004-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
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.
B
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.
C
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Symptomatic peripheral vascular disease
* Heart attack within 48 hours of surgery
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pfizer, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Fairhope, Alabama, United States
Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Fayetteville, Arkansas, United States
Pfizer Investigational Site
Springdale, Arkansas, United States
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
Sacramento, California, United States
Pfizer Investigational Site
Sacramento, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Santa Rosa, California, United States
Pfizer Investigational Site
Santa Rosa, California, United States
Pfizer Investigational Site
Stanford, California, United States
Pfizer Investigational Site
Fort Collins, Colorado, United States
Pfizer Investigational Site
Fort Collins, Colorado, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Brandon, Florida, United States
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Hudson, Florida, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Melbourne, Florida, United States
Pfizer Investigational Site
Melbourne, Florida, United States
Pfizer Investigational Site
Pensacola, Florida, United States
Pfizer Investigational Site
Pensacola, Florida, United States
Pfizer Investigational Site
Sarasota, Florida, United States
Pfizer Investigational Site
St. Petersburg, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Augusta, Georgia, United States
Pfizer Investigational Site
Fort Wayne, Indiana, United States
Pfizer Investigational Site
Iowa City, Iowa, United States
Pfizer Investigational Site
Kansas City, Kansas, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Salisbury, Maryland, United States
Pfizer Investigational Site
Takoma Park, Maryland, United States
Pfizer Investigational Site
Towson, Maryland, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Cambridge, Massachusetts, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
Livonia, Michigan, United States
Pfizer Investigational Site
Muskegon, Michigan, United States
Pfizer Investigational Site
Royal Oak, Michigan, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Dayton, Ohio, United States
Pfizer Investigational Site
Dayton, Ohio, United States
Pfizer Investigational Site
Sandusky, Ohio, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Tulsa, Oklahoma, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Altoona, Pennsylvania, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Amarillo, Texas, United States
Pfizer Investigational Site
Fort Worth, Texas, United States
Pfizer Investigational Site
Fort Worth, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Irving, Texas, United States
Pfizer Investigational Site
Burlington, Vermont, United States
Pfizer Investigational Site
Annandale, Virginia, United States
Pfizer Investigational Site
Falls Church, Virginia, United States
Pfizer Investigational Site
Fredericksburg, Virginia, United States
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
Tacoma, Washington, United States
Pfizer Investigational Site
Elkhorn, Wisconsin, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Pfizer Investigational Site
Morón, Pcia. de Buenos Aires, Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Auchenflower, Queensland, Australia
Pfizer Investigational Site
Ashford, South Australia, Australia
Pfizer Investigational Site
Clayton, Victoria, Australia
Pfizer Investigational Site
Graz, , Austria
Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Edegem, , Belgium
Pfizer Investigational Site
Genk, , Belgium
Pfizer Investigational Site
Liège, , Belgium
Pfizer Investigational Site
Edmonton, Alberta, Canada
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
Pfizer Investigational Site
Kingston, Ontario, Canada
Pfizer Investigational Site
Kingston, Ontario, Canada
Pfizer Investigational Site
London, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Fleurimont, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Regina, Saskatchewan, Canada
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Floridablanca, Santander Department, Colombia
Pfizer Investigational Site
Cali, Valle del Cauca Department, Colombia
Pfizer Investigational Site
Bogotá, , Colombia
Pfizer Investigational Site
České Budějovice, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Copenhagen, , Denmark
Pfizer Investigational Site
Odense C, , Denmark
Pfizer Investigational Site
Kuopio, , Finland
Pfizer Investigational Site
Kuopio, , Finland
Pfizer Investigational Site
Oulu, , Finland
Pfizer Investigational Site
Turku, , Finland
Pfizer Investigational Site
Aachen, , Germany
Pfizer Investigational Site
Bonn, , Germany
Pfizer Investigational Site
Giessen, , Germany
Pfizer Investigational Site
Göttingen, , Germany
Pfizer Investigational Site
Hamburg, , Germany
Pfizer Investigational Site
Heidelberg, , Germany
Pfizer Investigational Site
Kassel, , Germany
Pfizer Investigational Site
Kiel, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
Münster, , Germany
Pfizer Investigational Site
Dublin, , Ireland
Pfizer Investigational Site
Beersheba, , Israel
Pfizer Investigational Site
Haifa, , Israel
Pfizer Investigational Site
Haifa, , Israel
Pfizer Investigational Site
Holon, , Israel
Pfizer Investigational Site
Jerusalem, , Israel
Pfizer Investigational Site
Jerusalem, , Israel
Pfizer Investigational Site
Jerusalem, , Israel
Pfizer Investigational Site
Petah Tikva, , Israel
Pfizer Investigational Site
Ramat Gan, , Israel
Pfizer Investigational Site
Rehovot, , Israel
Pfizer Investigational Site
Tel Aviv, , Israel
Pfizer Investigational Site
Tel Litwinsky, , Israel
Pfizer Investigational Site
Florence, , Italy
Pfizer Investigational Site
Milan, , Italy
Pfizer Investigational Site
Pavia, , Italy
Pfizer Investigational Site
Pisa, , Italy
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
Pfizer Investigational Site
Mexico City, Mexico DF, Mexico
Pfizer Investigational Site
Mexico City, Mexico, DF, Mexico
Pfizer Investigational Site
Breda, , Netherlands
Pfizer Investigational Site
Eindhoven, , Netherlands
Pfizer Investigational Site
Zwolle, , Netherlands
Pfizer Investigational Site
Feiring, , Norway
Pfizer Investigational Site
Bialystok, , Poland
Pfizer Investigational Site
Krakow, , Poland
Pfizer Investigational Site
Poznan, , Poland
Pfizer Investigational Site
Szczecin, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Cluj-Napoca, , Romania
Pfizer Investigational Site
Timișoara, , Romania
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Singapore, , Singapore
Pfizer Investigational Site
Bratislava, , Slovakia
Pfizer Investigational Site
Košice, , Slovakia
Pfizer Investigational Site
Bloemfontein, Free State, South Africa
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa
Pfizer Investigational Site
Pretoria, Gauteng, South Africa
Pfizer Investigational Site
Pretoria, Gauteng, South Africa
Pfizer Investigational Site
Pretoria, Gauteng, South Africa
Pfizer Investigational Site
Pretoria, Gauteng, South Africa
Pfizer Investigational Site
Durban, KwaZulu-Natal, South Africa
Pfizer Investigational Site
Les Marais, Pretoria, South Africa
Pfizer Investigational Site
Parow, Western Cape, South Africa
Pfizer Investigational Site
Bloemfontein, , South Africa
Pfizer Investigational Site
Pretoria, , South Africa
Pfizer Investigational Site
Pretoria, , South Africa
Pfizer Investigational Site
Barcelona, , Spain
Pfizer Investigational Site
Barcelona, , Spain
Pfizer Investigational Site
Madrid, , Spain
Pfizer Investigational Site
Valencia, , Spain
Pfizer Investigational Site
Örebro, , Sweden
Pfizer Investigational Site
Stockholm, , Sweden
Pfizer Investigational Site
Uppsala, , Sweden
Pfizer Investigational Site
Bern, , Switzerland
Pfizer Investigational Site
Geneva, , Switzerland
Pfizer Investigational Site
Edinburgh, , United Kingdom
Pfizer Investigational Site
Liverpool, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
Middlesbrough, , United Kingdom
Pfizer Investigational Site
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A3481015
Identifier Type: -
Identifier Source: secondary_id
PARA-0505-071
Identifier Type: -
Identifier Source: org_study_id