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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00636064 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Parecoxib Sodium/Valdecoxib Drug: Placebo/Valdecoxib Other: Placebo/Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 1671 |
| Study Start Date: | January 2003 |
| Study Completion Date: | January 2004 |
| Arms | Assigned Interventions |
|---|---|
| A: Placebo Comparator |
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.
|
| B: Experimental |
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.
|
| C: Experimental |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Pfizer Investigational Site | |
| Fairhope, Alabama, United States, 36532 | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36602 | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36607 | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36608 | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Pfizer Investigational Site | |
| Fayetteville, Arkansas, United States, 72703 | |
| Pfizer Investigational Site | |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90095-1778 | |
| Pfizer Investigational Site | |
| STANFORD, California, United States, 94305 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94118-3110 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| Pfizer Investigational Site | |
| Sacramento, California, United States, 95819 | |
| Pfizer Investigational Site | |
| Sacramento, California, United States, 95825 | |
| Pfizer Investigational Site | |
| Orange, California, United States, 92868 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94143-0648 | |
| Pfizer Investigational Site | |
| Santa Rosa, California, United States, 95404 | |
| Pfizer Investigational Site | |
| Santa Rosa, California, United States, 95403 | |
| Pfizer Investigational Site | |
| Anaheim, California, United States, 92801 | |
| Pfizer Investigational Site | |
| Anaheim, California, United States, 92805 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Fort Collins, Colorado, United States, 80524 | |
| Pfizer Investigational Site | |
| Fort Collins, Colorado, United States, 80528 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06504 | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06520 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| SARASOTA, Florida, United States, 34239 | |
| Pfizer Investigational Site | |
| Sarasota, Florida, United States, 34239 | |
| 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 | |
| Clearwater, Florida, United States, 33756 | |
| Pfizer Investigational Site | |
| St. Petersburg, Florida, United States, 33709 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Hudson, Florida, United States, 34667 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Pensacola, Florida, United States, 32514 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33613 | |
| Pfizer Investigational Site | |
| Brandon, Florida, United States, 33511 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30322 | |
| Pfizer Investigational Site | |
| Augusta, Georgia, United States, 30901 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Fort Wayne, Indiana, United States, 46804 | |
| United States, Iowa | |
| Pfizer Investigational Site | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Towson, Maryland, United States, 21204 | |
| Pfizer Investigational Site | |
| Takoma Park, Maryland, United States, 20912 | |
| Pfizer Investigational Site | |
| Salisbury, Maryland, United States, 21801 | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Cambridge, Massachusetts, United States, 02138 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Royal Oak, Michigan, United States, 48073 | |
| Pfizer Investigational Site | |
| Muskegon, Michigan, United States, 49444 | |
| Pfizer Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| Pfizer Investigational Site | |
| Livonia, Michigan, United States, 48150 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Rochester, New York, United States, 14621 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Sandusky, Ohio, United States, 44870 | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45414 | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45408 | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45219 | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45236 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Tulsa, Oklahoma, United States, 74104 | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Pfizer Investigational Site | |
| Altoona, Pennsylvania, United States, 16601 | |
| Pfizer Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29401 | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29424 | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29425 | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29406 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | |
| Amarillo, Texas, United States, 79106 | |
| Pfizer Investigational Site | |
| Irving, Texas, United States, 75061 | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76107 | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76107-2699 | |
| United States, Vermont | |
| Pfizer Investigational Site | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| 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 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Elkhorn, Wisconsin, United States, 53121 | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Pfizer Investigational Site | |
| Madison, Wisconsin, United States, 53792 | |
| Argentina | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, C1405DCS | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1118 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1416 | |
| Argentina, Pcia. de Buenos Aires | |
| Pfizer Investigational Site | |
| Morón, Pcia. de Buenos Aires, Argentina, 1708 | |
| Australia, Queensland | |
| Pfizer Investigational Site | |
| Auchenflower, Queensland, Australia, 4066 | |
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Ashford, South Australia, Australia, 5035 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Clayton, Victoria, Australia, 3168 | |
| Austria | |
| Pfizer Investigational Site | |
| Graz, Austria, 8036 | |
| Belgium | |
| Pfizer Investigational Site | |
| Brussel, Belgium, 1090 | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium, 1070 | |
| Pfizer Investigational Site | |
| Liege, Belgium, B-4000 | |
| Pfizer Investigational Site | |
| Genk, Belgium, 3600 | |
| Pfizer Investigational Site | |
| Edegem, Belgium, 2650 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Nova Scotia | |
| Pfizer Investigational Site | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Pfizer Investigational Site | |
| London, Ontario, Canada, N6A 5A5 | |
| Pfizer Investigational Site | |
| Kingston, Ontario, Canada, K7L 5G2 | |
| Pfizer Investigational Site | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Pfizer Investigational Site | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Canada, Saskatchewan | |
| Pfizer Investigational Site | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Pfizer Investigational Site | |
| Regina, Saskatchewan, Canada, S4P 0W5 | |
| Colombia | |
| Pfizer Investigational Site | |
| Bogota, Colombia | |
| Colombia, Cundinamarca | |
| Pfizer Investigational Site | |
| Bogota, Cundinamarca, Colombia, 000 | |
| Colombia, Santander | |
| Pfizer Investigational Site | |
| Floridablanca, Santander, Colombia, 000 | |
| Colombia, Valle | |
| Pfizer Investigational Site | |
| Cali, Valle, Colombia, Nap | |
| Czech Republic | |
| 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 5, Czech Republic, 15500 | |
| Pfizer Investigational Site | |
| Prague, Czech Republic, 150 00 | |
| Pfizer Investigational Site | |
| Ceske Budejovice, Czech Republic, 370 87 | |
| Denmark | |
| Pfizer Investigational Site | |
| Odense C, Denmark, 5000 | |
| Pfizer Investigational Site | |
| Kobenhavn, Denmark, 2100 | |
| Finland | |
| Pfizer Investigational Site | |
| Kuopio, Finland, 70211 | |
| Pfizer Investigational Site | |
| Kuopio, Finland | |
| Pfizer Investigational Site | |
| Oulu, Finland | |
| Pfizer Investigational Site | |
| Turku, Finland, FIN-20520 | |
| Germany | |
| Pfizer Investigational Site | |
| Goettingen, Germany, 37075 | |
| Pfizer Investigational Site | |
| Giessen, Germany, 35385 | |
| Pfizer Investigational Site | |
| Bonn, Germany, 53105 | |
| Pfizer Investigational Site | |
| Heidelberg, Germany, 69120 | |
| Pfizer Investigational Site | |
| Kiel, Germany, 24105 | |
| Pfizer Investigational Site | |
| Muenster, Germany, 48149 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 81377 | |
| Pfizer Investigational Site | |
| Hamburg, Germany, 20251 | |
| Pfizer Investigational Site | |
| Kassel, Germany, 34125 | |
| Pfizer Investigational Site | |
| Aachen, Germany, 52074 | |
| Ireland | |
| Pfizer Investigational Site | |
| Dublin, Ireland | |
| Pfizer Investigational Site | |
| Dublin, Ireland | |
| Israel | |
| Pfizer Investigational Site | |
| Haifa, Israel, 34362 | |
| Pfizer Investigational Site | |
| Jerusalem, Israel, 91004 | |
| Pfizer Investigational Site | |
| Ramat-Gan, Israel | |
| Pfizer Investigational Site | |
| Tel Hashomer, Israel, 52651 | |
| Pfizer Investigational Site | |
| Petach-Tikva, Israel, 49261 | |
| Pfizer Investigational Site | |
| Holon, Israel, 58100 | |
| Pfizer Investigational Site | |
| Tel Aviv, Israel | |
| Pfizer Investigational Site | |
| Beer Sheva, Israel | |
| Pfizer Investigational Site | |
| Haifa, Israel | |
| Pfizer Investigational Site | |
| Jerusalem, Israel, 91031 | |
| Pfizer Investigational Site | |
| Jerusalem, Israel, 91120 | |
| Pfizer Investigational Site | |
| Rehovot, Israel | |
| Italy | |
| Pfizer Investigational Site | |
| Pisa, Italy, 56125 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20138 | |
| Pfizer Investigational Site | |
| Pavia, Italy, 27100 | |
| Pfizer Investigational Site | |
| Firenze, Italy, 50134 | |
| Mexico, DF | |
| Pfizer Investigational Site | |
| Mexico City, DF, Mexico, 14050 | |
| Pfizer Investigational Site | |
| Mexico City, DF, Mexico, 06720 | |
| Pfizer Investigational Site | |
| Mexico City, DF, Mexico, 03100 | |
| Mexico, Mexico DF | |
| Pfizer Investigational Site | |
| Mexico City, Mexico DF, Mexico, 07760 | |
| Mexico, Mexico, DF | |
| Pfizer Investigational Site | |
| Mexico City, Mexico, DF, Mexico, 14000 | |
| Netherlands | |
| Pfizer Investigational Site | |
| Eindhoven, Netherlands, 5623 EJ | |
| Pfizer Investigational Site | |
| Zwolle, Netherlands, 8011 JW | |
| Pfizer Investigational Site | |
| Breda, Netherlands, 4836 AE | |
| Norway | |
| Pfizer Investigational Site | |
| Feiring, Norway, 2093 | |
| Poland | |
| Pfizer Investigational Site | |
| Bialystok, Poland, 15-276 | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 02-097 | |
| Pfizer Investigational Site | |
| Krakow, Poland, 31-202 | |
| Pfizer Investigational Site | |
| Poznan, Poland, 61-848 | |
| Pfizer Investigational Site | |
| Szczecin, Poland, 70-111 | |
| Romania | |
| Pfizer Investigational Site | |
| Bucharest, Romania, 771181 | |
| Pfizer Investigational Site | |
| Bucuresti, Romania, 7000 | |
| Pfizer Investigational Site | |
| Timisoara, Romania, 1900 | |
| Pfizer Investigational Site | |
| Cluj-Napoca, Romania, 3400 | |
| Pfizer Investigational Site | |
| Bucuresti, Romania, 71406 | |
| Pfizer Investigational Site | |
| Bucharest, Romania, 7000 | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 123182 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 119992 | |
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 168752 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 040-11 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 833 48 | |
| South Africa | |
| Pfizer Investigational Site | |
| Bloemfontein, South Africa, 9300 | |
| Pfizer Investigational Site | |
| Pretoria, South Africa, 0040 | |
| Pfizer Investigational Site | |
| Pretoria, South Africa, 0002 | |
| South Africa, Free State | |
| Pfizer Investigational Site | |
| Bloemfontein, Free State, South Africa | |
| South Africa, Gauteng | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng, South Africa, 0084 | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng, South Africa, 0002 | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng, South Africa | |
| South Africa, Gauteng Province | |
| Pfizer Investigational Site | |
| Johannesburg, Gauteng Province, South Africa | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng Province, South Africa, 0140 | |
| South Africa, KwaZulu Natal | |
| Pfizer Investigational Site | |
| Durban, KwaZulu Natal, South Africa | |
| South Africa, Pretoria | |
| Pfizer Investigational Site | |
| Les Marais, Pretoria, South Africa, 0084 | |
| South Africa, Western Cape | |
| Pfizer Investigational Site | |
| Parow, Western Cape, South Africa, 7500 | |
| Spain | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46010 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08025 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08907 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28046 | |
| Sweden | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 171 76 | |
| Pfizer Investigational Site | |
| Uppsala, Sweden, SE 751 85 | |
| Pfizer Investigational Site | |
| Orebro, Sweden, SE-701 85 | |
| Switzerland | |
| Pfizer Investigational Site | |
| Bern, Switzerland, 3010 | |
| Pfizer Investigational Site | |
| Geneve 14, Switzerland, 1211 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Middlesbrough, United Kingdom, TS4 3BW | |
| Pfizer Investigational Site | |
| Edinburgh, United Kingdom, Eh3 9YW | |
| Pfizer Investigational Site | |
| Oxford, United Kingdom, OX3 9DU | |
| Pfizer Investigational Site | |
| London, United Kingdom, SE1 7EH | |
| Pfizer Investigational Site | |
| Liverpool, United Kingdom | |
| Pfizer Investigational Site | |
| London, United Kingdom, E2 9JX | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | PARA-0505-071, A3481015 |
| Study First Received: | March 7, 2008 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00636064 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Inflammatory Agents Parecoxib Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Valdecoxib Antirheumatic Agents Central Nervous System Agents |
