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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,671

Participants

Timeline

Start Date

January 31, 2003

Study Completion Date

January 31, 2004

Conditions
Pain
Interventions
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.

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.

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.

Trial Locations (206)

1070

Pfizer Investigational Site, Brussels

1090

Pfizer Investigational Site, Brussels

1118

Pfizer Investigational Site, Buenos Aires

1211

Pfizer Investigational Site, Geneva

1416

Pfizer Investigational Site, Buenos Aires

1708

Pfizer Investigational Site, Morón

1900

Pfizer Investigational Site, Timișoara

2093

Pfizer Investigational Site, Feiring

2100

Pfizer Investigational Site, Copenhagen

2650

Pfizer Investigational Site, Edegem

3010

Pfizer Investigational Site, Bern

3168

Pfizer Investigational Site, Clayton

3400

Pfizer Investigational Site, Cluj-Napoca

3600

Pfizer Investigational Site, Genk

4066

Pfizer Investigational Site, Auchenflower

5000

Pfizer Investigational Site, Odense C

5035

Pfizer Investigational Site, Ashford

7000

Pfizer Investigational Site, Bucharest

7500

Pfizer Investigational Site, Parow

8036

Pfizer Investigational Site, Graz

9300

Pfizer Investigational Site, Bloemfontein

10029

Pfizer Investigational Site, New York

14000

Pfizer Investigational Site, Mexico City

14050

Pfizer Investigational Site, Mexico City

14220

Pfizer Investigational Site, Prague

14621

Pfizer Investigational Site, Rochester

15212

Pfizer Investigational Site, Pittsburgh

15224

Pfizer Investigational Site, Pittsburgh

15500

Pfizer Investigational Site, Prague

16601

Pfizer Investigational Site, Altoona

20010

Pfizer Investigational Site, Washington D.C.

20138

Pfizer Investigational Site, Milan

20251

Pfizer Investigational Site, Hamburg

20912

Pfizer Investigational Site, Takoma Park

21204

Pfizer Investigational Site, Towson

21215

Pfizer Investigational Site, Baltimore

21801

Pfizer Investigational Site, Salisbury

22003

Pfizer Investigational Site, Annandale

22042

Pfizer Investigational Site, Falls Church

22401

Pfizer Investigational Site, Fredericksburg

23507

Pfizer Investigational Site, Norfolk

24105

Pfizer Investigational Site, Kiel

27100

Pfizer Investigational Site, Pavia

28046

Pfizer Investigational Site, Madrid

29401

Pfizer Investigational Site, Charleston

29406

Pfizer Investigational Site, Charleston

29424

Pfizer Investigational Site, Charleston

29425

Pfizer Investigational Site, Charleston

30322

Pfizer Investigational Site, Atlanta

30901

Pfizer Investigational Site, Augusta

32216

Pfizer Investigational Site, Jacksonville

32504

Pfizer Investigational Site, Pensacola

32514

Pfizer Investigational Site, Pensacola

32901

Pfizer Investigational Site, Melbourne

33511

Pfizer Investigational Site, Brandon

33613

Pfizer Investigational Site, Tampa

33709

Pfizer Investigational Site, St. Petersburg

33756

Pfizer Investigational Site, Clearwater

34125

Pfizer Investigational Site, Kassel

34239

Pfizer Investigational Site, Sarasota

34362

Pfizer Investigational Site, Haifa

34667

Pfizer Investigational Site, Hudson

35385

Pfizer Investigational Site, Giessen

36532

Pfizer Investigational Site, Fairhope

36602

Pfizer Investigational Site, Mobile

36604

Pfizer Investigational Site, Mobile

36607

Pfizer Investigational Site, Mobile

36608

Pfizer Investigational Site, Mobile

37075

Pfizer Investigational Site, Göttingen

38120

Pfizer Investigational Site, Memphis

44870

Pfizer Investigational Site, Sandusky

45219

Pfizer Investigational Site, Cincinnati

45236

Pfizer Investigational Site, Cincinnati

45408

Pfizer Investigational Site, Dayton

45414

Pfizer Investigational Site, Dayton

46010

Pfizer Investigational Site, Valencia

46804

Pfizer Investigational Site, Fort Wayne

48073

Pfizer Investigational Site, Royal Oak

48149

Pfizer Investigational Site, Münster

48150

Pfizer Investigational Site, Livonia

48202

Pfizer Investigational Site, Detroit

49261

Pfizer Investigational Site, Petah Tikva

49444

Pfizer Investigational Site, Muskegon

50134

Pfizer Investigational Site, Florence

52074

Pfizer Investigational Site, Aachen

52242

Pfizer Investigational Site, Iowa City

52651

Pfizer Investigational Site, Tel Litwinsky

53105

Pfizer Investigational Site, Bonn

53121

Pfizer Investigational Site, Elkhorn

53215

Pfizer Investigational Site, Milwaukee

53792

Pfizer Investigational Site, Madison

56125

Pfizer Investigational Site, Pisa

58100

Pfizer Investigational Site, Holon

66160

Pfizer Investigational Site, Kansas City

69120

Pfizer Investigational Site, Heidelberg

70211

Pfizer Investigational Site, Kuopio

71406

Pfizer Investigational Site, Bucharest

72703

Pfizer Investigational Site, Fayetteville

72764

Pfizer Investigational Site, Springdale

73112

Pfizer Investigational Site, Oklahoma City

74104

Pfizer Investigational Site, Tulsa

75061

Pfizer Investigational Site, Irving

76107

Pfizer Investigational Site, Fort Worth

77030

Pfizer Investigational Site, Houston

79106

Pfizer Investigational Site, Amarillo

80524

Pfizer Investigational Site, Fort Collins

80528

Pfizer Investigational Site, Fort Collins

81377

Pfizer Investigational Site, München

85724

Pfizer Investigational Site, Tucson

90033

Pfizer Investigational Site, Los Angeles

91004

Pfizer Investigational Site, Jerusalem

91031

Pfizer Investigational Site, Jerusalem

91120

Pfizer Investigational Site, Jerusalem

92801

Pfizer Investigational Site, Anaheim

92805

Pfizer Investigational Site, Anaheim

92868

Pfizer Investigational Site, Orange

94115

Pfizer Investigational Site, San Francisco

94305

Pfizer Investigational Site, Stanford

95403

Pfizer Investigational Site, Santa Rosa

95404

Pfizer Investigational Site, Santa Rosa

95819

Pfizer Investigational Site, Sacramento

95825

Pfizer Investigational Site, Sacramento

97210

Pfizer Investigational Site, Portland

98405

Pfizer Investigational Site, Tacoma

119992

Pfizer Investigational Site, Moscow

123182

Pfizer Investigational Site, Moscow

168752

Pfizer Investigational Site, Singapore

771181

Pfizer Investigational Site, Bucharest

90095-1778

Pfizer Investigational Site, Los Angeles

94118-3110

Pfizer Investigational Site, San Francisco

94143-0648

Pfizer Investigational Site, San Francisco

06504

Pfizer Investigational Site, New Haven

06520

Pfizer Investigational Site, New Haven

32901-3276

Pfizer Investigational Site, Melbourne

02215

Pfizer Investigational Site, Boston

02138

Pfizer Investigational Site, Cambridge

76107-2699

Pfizer Investigational Site, Fort Worth

05401

Pfizer Investigational Site, Burlington

C1405DCS

Pfizer Investigational Site, Buenos Aires

B-4000

Pfizer Investigational Site, Liège

T6G 2B7

Pfizer Investigational Site, Edmonton

V5Z 1M9

Pfizer Investigational Site, Vancouver

V6Z 1Y6

Pfizer Investigational Site, Vancouver

R3A 1R9

Pfizer Investigational Site, Winnipeg

B3H 3A7

Pfizer Investigational Site, Halifax

K7L 2V7

Pfizer Investigational Site, Kingston

K7L 5G2

Pfizer Investigational Site, Kingston

N6A 5A5

Pfizer Investigational Site, London

M4N 3M5

Pfizer Investigational Site, Toronto

M5G 2C4

Pfizer Investigational Site, Toronto

J1H 5N4

Pfizer Investigational Site, Fleurimont

H1T 1C8

Pfizer Investigational Site, Montreal

H3A 1A1

Pfizer Investigational Site, Montreal

S4P 0W5

Pfizer Investigational Site, Regina

S7N 0W8

Pfizer Investigational Site, Saskatoon

000

Pfizer Investigational Site, Bogota

Pfizer Investigational Site, Floridablanca

Nap

Pfizer Investigational Site, Santiago de Cali

Unknown

Pfizer Investigational Site, Bogotá

Pfizer Investigational Site, Kuopio

Pfizer Investigational Site, Oulu

Pfizer Investigational Site, Dublin

Pfizer Investigational Site, Beersheba

Pfizer Investigational Site, Haifa

Pfizer Investigational Site, Ramat Gan

Pfizer Investigational Site, Rehovot

Pfizer Investigational Site, Tel Aviv

Pfizer Investigational Site, Bloemfontein

Pfizer Investigational Site, Johannesburg

Pfizer Investigational Site, Pretoria

Pfizer Investigational Site, Durban

Pfizer Investigational Site, Liverpool

370 87

Pfizer Investigational Site, České Budějovice

100 34

Pfizer Investigational Site, Prague

128 00

Pfizer Investigational Site, Prague

150 00

Pfizer Investigational Site, Prague

FIN-20520

Pfizer Investigational Site, Turku

03100

Pfizer Investigational Site, Mexico City

06720

Pfizer Investigational Site, Mexico City

07760

Pfizer Investigational Site, Mexico City

4836 AE

Pfizer Investigational Site, Breda

5623 EJ

Pfizer Investigational Site, Eindhoven

8011 JW

Pfizer Investigational Site, Zwolle

15-276

Pfizer Investigational Site, Bialystok

31-202

Pfizer Investigational Site, Krakow

61-848

Pfizer Investigational Site, Poznan

70-111

Pfizer Investigational Site, Szczecin

02-097

Pfizer Investigational Site, Warsaw

833 48

Pfizer Investigational Site, Bratislava

040-11

Pfizer Investigational Site, Košice

0002

Pfizer Investigational Site, Pretoria

Pfizer Investigational Site, Pretoria

0084

Pfizer Investigational Site, Pretoria

Pfizer Investigational Site, Les Marais

0140

Pfizer Investigational Site, Pretoria

0040

Pfizer Investigational Site, Pretoria

08025

Pfizer Investigational Site, Barcelona

08907

Pfizer Investigational Site, Barcelona

SE-701 85

Pfizer Investigational Site, Örebro

171 76

Pfizer Investigational Site, Stockholm

SE 751 85

Pfizer Investigational Site, Uppsala

Eh3 9YW

Pfizer Investigational Site, Edinburgh

E2 9JX

Pfizer Investigational Site, London

SE1 7EH

Pfizer Investigational Site, London

TS4 3BW

Pfizer Investigational Site, Middlesbrough

OX3 9DU

Pfizer Investigational Site, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00636064 - 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 | Biotech Hunter | Biotech Hunter