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NCT00636064 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00636064
Other study ID # PARA-0505-071
Secondary ID A3481015
Status Completed
Phase Phase 3
First received March 7, 2008
Last updated October 9, 2008
Start date January 2003
Est. completion date January 2004

Study information
Verified date March 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 1671
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Morón Pcia. de Buenos Aires
Australia Pfizer Investigational Site Ashford South Australia
Australia Pfizer Investigational Site Auchenflower Queensland
Australia Pfizer Investigational Site Clayton Victoria
Austria Pfizer Investigational Site Graz
Belgium Pfizer Investigational Site Brussel
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Edegem
Belgium Pfizer Investigational Site Genk
Belgium Pfizer Investigational Site Liege
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Fleurimont Quebec
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 Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Regina Saskatchewan
Canada Pfizer Investigational Site Saskatoon Saskatchewan
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Winnipeg Manitoba
Colombia Pfizer Investigational Site Bogota Cundinamarca
Colombia Pfizer Investigational Site Bogota
Colombia Pfizer Investigational Site Cali Valle
Colombia Pfizer Investigational Site Floridablanca Santander
Czech Republic Pfizer Investigational Site Ceske Budejovice
Czech Republic Pfizer Investigational Site Prague
Czech Republic Pfizer Investigational Site Prague
Czech Republic Pfizer Investigational Site Prague
Czech Republic Pfizer Investigational Site Prague
Czech Republic Pfizer Investigational Site Prague 5
Denmark Pfizer Investigational Site Kobenhavn
Denmark Pfizer Investigational Site Odense C
Finland Pfizer Investigational Site Kuopio
Finland Pfizer Investigational Site Kuopio
Finland Pfizer Investigational Site Oulu
Finland Pfizer Investigational Site Turku
Germany Pfizer Investigational Site Aachen
Germany Pfizer Investigational Site Bonn
Germany Pfizer Investigational Site Giessen
Germany Pfizer Investigational Site Goettingen
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Heidelberg
Germany Pfizer Investigational Site Kassel
Germany Pfizer Investigational Site Kiel
Germany Pfizer Investigational Site Muenchen
Germany Pfizer Investigational Site Muenster
Ireland Pfizer Investigational Site Dublin
Israel Pfizer Investigational Site Beer Sheva
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 Petach-Tikva
Israel Pfizer Investigational Site Ramat-Gan
Israel Pfizer Investigational Site Rehovot
Israel Pfizer Investigational Site Tel Aviv
Israel Pfizer Investigational Site Tel Hashomer
Italy Pfizer Investigational Site Firenze
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Pavia
Italy Pfizer Investigational Site Pisa
Mexico Pfizer Investigational Site Mexico City DF
Mexico Pfizer Investigational Site Mexico City DF
Mexico Pfizer Investigational Site Mexico City DF
Mexico Pfizer Investigational Site Mexico City Mexico DF
Mexico Pfizer Investigational Site Mexico City Mexico, DF
Netherlands Pfizer Investigational Site Breda
Netherlands Pfizer Investigational Site Eindhoven
Netherlands Pfizer Investigational Site Zwolle
Norway Pfizer Investigational Site Feiring
Poland Pfizer Investigational Site Bialystok
Poland Pfizer Investigational Site Krakow
Poland Pfizer Investigational Site Poznan
Poland Pfizer Investigational Site Szczecin
Poland Pfizer Investigational Site Warszawa
Romania Pfizer Investigational Site Bucharest
Romania Pfizer Investigational Site Bucharest
Romania Pfizer Investigational Site Bucuresti
Romania Pfizer Investigational Site Bucuresti
Romania Pfizer Investigational Site Cluj-Napoca
Romania Pfizer Investigational Site Timisoara
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Singapore Pfizer Investigational Site Singapore
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Kosice
South Africa Pfizer Investigational Site Bloemfontein Free State
South Africa Pfizer Investigational Site Bloemfontein
South Africa Pfizer Investigational Site Durban KwaZulu Natal
South Africa Pfizer Investigational Site Johannesburg Gauteng Province
South Africa Pfizer Investigational Site Les Marais Pretoria
South Africa Pfizer Investigational Site Parow Western Cape
South Africa Pfizer Investigational Site Pretoria
South Africa Pfizer Investigational Site Pretoria
South Africa Pfizer Investigational Site Pretoria Gauteng Province
South Africa Pfizer Investigational Site Pretoria Gauteng
South Africa Pfizer Investigational Site Pretoria Gauteng
South Africa Pfizer Investigational Site Pretoria Gauteng
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Valencia
Sweden Pfizer Investigational Site Orebro
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Uppsala
Switzerland Pfizer Investigational Site Bern
Switzerland Pfizer Investigational Site Geneve 14
United Kingdom 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 States Pfizer Investigational Site Altoona Pennsylvania
United States Pfizer Investigational Site Amarillo Texas
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Annandale Virginia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Augusta Georgia
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Brandon Florida
United States Pfizer Investigational Site Burlington Vermont
United States Pfizer Investigational Site Cambridge Massachusetts
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 Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site Elkhorn Wisconsin
United States Pfizer Investigational Site Fairhope Alabama
United States Pfizer Investigational Site Falls Church Virginia
United States Pfizer Investigational Site Fayetteville Arkansas
United States Pfizer Investigational Site Fort Collins Colorado
United States Pfizer Investigational Site Fort Collins Colorado
United States Pfizer Investigational Site Fort Wayne Indiana
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Fredericksburg Virginia
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Hudson Florida
United States Pfizer Investigational Site Iowa City Iowa
United States Pfizer Investigational Site Irving Texas
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Kansas City Kansas
United States Pfizer Investigational Site Livonia Michigan
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Melbourne Florida
United States Pfizer Investigational Site Melbourne Florida
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Milwaukee Wisconsin
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 Muskegon Michigan
United States Pfizer Investigational Site New Haven Connecticut
United States Pfizer Investigational Site New Haven Connecticut
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Orange California
United States Pfizer Investigational Site Pensacola Florida
United States Pfizer Investigational Site Pensacola Florida
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Royal Oak Michigan
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site Salisbury Maryland
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 Sandusky Ohio
United States Pfizer Investigational Site Santa Rosa California
United States Pfizer Investigational Site Santa Rosa California
United States Pfizer Investigational Site Sarasota Florida
United States Pfizer Investigational Site Springdale Arkansas
United States Pfizer Investigational Site St. Petersburg Florida
United States Pfizer Investigational Site Stanford California
United States Pfizer Investigational Site Tacoma Washington
United States Pfizer Investigational Site Takoma Park Maryland
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Towson Maryland
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

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, 

Outcome
Type Measure Description Time frame Safety issue
Primary Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE) Day 30 No
Secondary 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 No
Secondary Rate of supplemental analgesia consumed Days 1-10 No
Secondary Vital signs Day 30 No
Secondary Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8) Day 1 No
Secondary Opioid-related Symptoms Distress Scale (OR-SDS) Days 1-10 No
Secondary Time to last Patient Controlled Analgesia (PCA) dose No
Secondary Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge) No
Secondary 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 No
Secondary Adverse events Day 30 No
Secondary Serious adverse events Day 30 No
Secondary Clinical laboratory assessments Day 30 No
Secondary Peak Pain Intensity (PPI) of sternotomy alone and overall body pain Days 1-10 No
Secondary Patient's and Physician's Global Evaluation of Study Medication At time of transition from intravenous to oral medication and final visit/early termination No
Secondary Modified Brief Pain Inventory-short form (mBPI-sf) Days 1-10 No
Secondary SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24) Days 1-10 No
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