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

NCT00636064 | Completed Phase 3 DMC

• 2 other identifiers: PARA-0505-071A3481015
• Study Type: interventional
• Target: 1,671
• Locations: 26 countries
• Sites: 205

Brief 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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE)

  Day 30

Secondary Outcomes (15)

• 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

• Vital signs

  Day 30

• 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

Study Arms (3)

A

PLACEBO COMPARATOR

Drug: Parecoxib Sodium/Valdecoxib

B

EXPERIMENTAL

Drug: Placebo/Valdecoxib

C

EXPERIMENTAL

Other: Placebo/Placebo

Interventions

Parecoxib Sodium/Valdecoxib DRUG

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.

A

Placebo/Valdecoxib DRUG

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.

B

Placebo/Placebo OTHER

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.

C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (206)

Pfizer Investigational Site

Fairhope, Alabama, 36532, United States

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Mobile, Alabama, 36602, United States

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Mobile, Alabama, 36604, United States

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Mobile, Alabama, 36607, United States

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Mobile, Alabama, 36608, United States

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Tucson, Arizona, 85724, United States

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Fayetteville, Arkansas, 72703, United States

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Springdale, Arkansas, 72764, United States

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Anaheim, California, 92801, United States

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Anaheim, California, 92805, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90095-1778, United States

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Orange, California, 92868, United States

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Sacramento, California, 95819, United States

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Sacramento, California, 95825, United States

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San Francisco, California, 94115, United States

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San Francisco, California, 94118-3110, United States

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San Francisco, California, 94143-0648, United States

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Santa Rosa, California, 95403, United States

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Santa Rosa, California, 95404, United States

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Stanford, California, 94305, United States

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Fort Collins, Colorado, 80524, United States

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Fort Collins, Colorado, 80528, United States

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New Haven, Connecticut, 06504, United States

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New Haven, Connecticut, 06520, United States

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Washington D.C., District of Columbia, 20010, United States

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Brandon, Florida, 33511, United States

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Clearwater, Florida, 33756, United States

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Hudson, Florida, 34667, United States

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Jacksonville, Florida, 32216, United States

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Melbourne, Florida, 32901-3276, United States

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Melbourne, Florida, 32901, United States

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Pensacola, Florida, 32504, United States

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Pensacola, Florida, 32514, United States

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Sarasota, Florida, 34239, United States

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St. Petersburg, Florida, 33709, United States

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Tampa, Florida, 33613, United States

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Atlanta, Georgia, 30322, United States

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Augusta, Georgia, 30901, United States

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Fort Wayne, Indiana, 46804, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Baltimore, Maryland, 21215, United States

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Salisbury, Maryland, 21801, United States

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Takoma Park, Maryland, 20912, United States

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Towson, Maryland, 21204, United States

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Boston, Massachusetts, 02215, United States

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Cambridge, Massachusetts, 02138, United States

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Detroit, Michigan, 48202, United States

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Livonia, Michigan, 48150, United States

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Muskegon, Michigan, 49444, United States

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Royal Oak, Michigan, 48073, United States

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New York, New York, 10029, United States

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Rochester, New York, 14621, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45236, United States

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Dayton, Ohio, 45408, United States

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Dayton, Ohio, 45414, United States

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Sandusky, Ohio, 44870, United States

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Oklahoma City, Oklahoma, 73112, United States

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Tulsa, Oklahoma, 74104, United States

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Portland, Oregon, 97210, United States

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Altoona, Pennsylvania, 16601, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Pittsburgh, Pennsylvania, 15224, United States

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Charleston, South Carolina, 29401, United States

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Charleston, South Carolina, 29406, United States

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Charleston, South Carolina, 29424, United States

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Charleston, South Carolina, 29425, United States

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Memphis, Tennessee, 38120, United States

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Amarillo, Texas, 79106, United States

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Fort Worth, Texas, 76107-2699, United States

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Fort Worth, Texas, 76107, United States

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Houston, Texas, 77030, United States

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Irving, Texas, 75061, United States

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Burlington, Vermont, 05401, United States

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Annandale, Virginia, 22003, United States

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Falls Church, Virginia, 22042, United States

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Fredericksburg, Virginia, 22401, United States

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Norfolk, Virginia, 23507, United States

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Tacoma, Washington, 98405, United States

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Elkhorn, Wisconsin, 53121, United States

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Madison, Wisconsin, 53792, United States

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Milwaukee, Wisconsin, 53215, United States

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Morón, Pcia. de Buenos Aires, 1708, Argentina

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Buenos Aires, 1118, Argentina

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Buenos Aires, 1416, Argentina

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Buenos Aires, C1405DCS, Argentina

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Auchenflower, Queensland, 4066, Australia

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Ashford, South Australia, 5035, Australia

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Clayton, Victoria, 3168, Australia

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Graz, 8036, Austria

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Edegem, 2650, Belgium

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Genk, 3600, Belgium

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Liège, B-4000, Belgium

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Edmonton, Alberta, T6G 2B7, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Vancouver, British Columbia, V6Z 1Y6, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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Kingston, Ontario, K7L 2V7, Canada

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Kingston, Ontario, K7L 5G2, Canada

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London, Ontario, N6A 5A5, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Fleurimont, Quebec, J1H 5N4, Canada

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Montreal, Quebec, H1T 1C8, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Regina, Saskatchewan, S4P 0W5, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Bogota, Cundinamarca, 000, Colombia

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Floridablanca, Santander Department, 000, Colombia

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Cali, Valle del Cauca Department, Nap, Colombia

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Bogotá, Colombia

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České Budějovice, 370 87, Czechia

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Prague, 100 34, Czechia

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Prague, 128 00, Czechia

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Prague, 14220, Czechia

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Prague, 150 00, Czechia

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Prague, 15500, Czechia

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Copenhagen, 2100, Denmark

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Odense C, 5000, Denmark

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Kuopio, 70211, Finland

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Kuopio, Finland

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Oulu, Finland

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Turku, FIN-20520, Finland

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Aachen, 52074, Germany

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Bonn, 53105, Germany

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Giessen, 35385, Germany

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Göttingen, 37075, Germany

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Hamburg, 20251, Germany

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Heidelberg, 69120, Germany

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Kassel, 34125, Germany

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Kiel, 24105, Germany

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München, 81377, Germany

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Münster, 48149, Germany

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Dublin, Ireland

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Beersheba, Israel

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Haifa, 34362, Israel

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Haifa, Israel

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Holon, 58100, Israel

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Jerusalem, 91004, Israel

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Jerusalem, 91031, Israel

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Jerusalem, 91120, Israel

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Petah Tikva, 49261, Israel

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Ramat Gan, Israel

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Rehovot, Israel

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Tel Aviv, Israel

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Tel Litwinsky, 52651, Israel

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Florence, 50134, Italy

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Milan, 20138, Italy

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Pavia, 27100, Italy

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Pisa, 56125, Italy

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Mexico City, Mexico City, 03100, Mexico

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Mexico City, Mexico City, 06720, Mexico

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Mexico City, Mexico City, 14050, Mexico

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Mexico City, Mexico DF, 07760, Mexico

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Mexico City, Mexico, DF, 14000, Mexico

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Breda, 4836 AE, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Zwolle, 8011 JW, Netherlands

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Feiring, 2093, Norway

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Bialystok, 15-276, Poland

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Krakow, 31-202, Poland

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Poznan, 61-848, Poland

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Szczecin, 70-111, Poland

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Warsaw, 02-097, Poland

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Bucharest, 7000, Romania

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Bucharest, 71406, Romania

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Bucharest, 771181, Romania

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Cluj-Napoca, 3400, Romania

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Timișoara, 1900, Romania

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Moscow, 119992, Russia

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Moscow, 123182, Russia

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Singapore, 168752, Singapore

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Bratislava, 833 48, Slovakia

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Košice, 040-11, Slovakia

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Bloemfontein, Free State, South Africa

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, 0002, South Africa

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Pretoria, Gauteng, 0084, South Africa

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Pretoria, Gauteng, 0140, South Africa

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Les Marais, Pretoria, 0084, South Africa

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Parow, Western Cape, 7500, South Africa

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Bloemfontein, 9300, South Africa

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Pretoria, 0002, South Africa

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Pretoria, 0040, South Africa

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Barcelona, 08025, Spain

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Barcelona, 08907, Spain

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Madrid, 28046, Spain

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Valencia, 46010, Spain

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Örebro, SE-701 85, Sweden

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Stockholm, 171 76, Sweden

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Uppsala, SE 751 85, Sweden

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Bern, 3010, Switzerland

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Geneva, 1211, Switzerland

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Edinburgh, Eh3 9YW, United Kingdom

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Liverpool, United Kingdom

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London, E2 9JX, United Kingdom

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London, SE1 7EH, United Kingdom

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Middlesbrough, TS4 3BW, United Kingdom

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Oxford, OX3 9DU, United Kingdom

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Related Links

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

MeSH Terms

Conditions

Pain

Interventions

parecoxib; valdecoxib

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Study Start: January 1, 2003
• Study Completion: January 1, 2004
• Last Updated: October 10, 2008

Record last verified: 2008-03

Locations

AU (3); NL (3); BE (5); RO (5); SG (1); RU (2); CO (4); IE (1); FI (4); SE (3); IL (12); DE (10); PL (5); ES (4); CZ (6); SL (2); GB (6); ME (5); US (84); IT (4); ZA (12); AR (4); CH (2); DK (2); CA (15); NO (1)