Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction

PHASE3CompletedINTERVENTIONAL
Enrollment

488

Participants

Timeline

Start Date

March 31, 2004

Study Completion Date

February 28, 2005

Conditions
Pain
Interventions
DRUG

placebo

valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5.

DRUG

valdecoxib

valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.

DRUG

valdecoxib

valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.

Trial Locations (81)

21093

Pfizer Investigational Site, Timonium

21218

Pfizer Investigational Site, Baltimore

22031

Pfizer Investigational Site, Fairfax

22205

Pfizer Investigational Site, Arlington

29110

Pfizer Investigational Site, Orangeburg

29202

Pfizer Investigational Site, Columbia

29204

Pfizer Investigational Site, Columbia

29212

Pfizer Investigational Site, Cola

29621

Pfizer Investigational Site, Anderson

30260

Pfizer Investigational Site, Morrow

30281

Pfizer Investigational Site, Stockbridge

30327

Pfizer Investigational Site, Atlanta

32086

Pfizer Investigational Site, Saint Augustine

32216

Pfizer Investigational Site, Jacksonville

32250

Pfizer Investigational Site, Jacksonville

33021

Pfizer Investigational Site, Hollywood

33324

Pfizer Investigational Site, Plantation

33326

Pfizer Investigational Site, Weston

33703

Pfizer Investigational Site, St. Petersburg

35205

Pfizer Investigational Site, Birmingham

35476

Pfizer Investigational Site, Northport

36205

Pfizer Investigational Site, Birmingham

40504

Pfizer Investigational Site, Lexington

40509

Pfizer Investigational Site, Lexington

48073

Pfizer Investigational Site, Royal Oak

48085

Pfizer Investigational Site, Troy

52401

Pfizer Investigational Site, Cedar Rapids

60304

Pfizer Investigational Site, Chicago

Pfizer Investigational Site, Oak Park

60612

Pfizer Investigational Site, Chicago

65804

Pfizer Investigational Site, Springfield

65807

Pfizer Investigational Site, Springfield

75231

Pfizer Investigational Site, Dallas

76104

Pfizer Investigational Site, Fort Worth

76107

Pfizer Investigational Site, Fort Worth

78127

Pfizer Investigational Site, San Antonio

78209

Pfizer Investigational Site, San Antonio

78217

Pfizer Investigational Site, San Antonio

78229

Pfizer Investigational Site, San Antonio

78240

Pfizer Investigational Site, San Antonio

78666

Pfizer Investigational Site, San Marcos

78705

Pfizer Investigational Site, Austin

85006

Pfizer Investigational Site, Pheonix

85008

Pfizer Investigational Site, Pheonix

85016

Pfizer Investigational Site, Pheonix

Pfizer Investigational Site, Phoenix

85032

Pfizer Investigational Site, Phoenix

85281

Pfizer Investigational Site, Tempe

85310

Pfizer Investigational Site, Glendale

89106

Pfizer Investigational Site, Las Vegas

89117

Pfizer Investigational Site, Las Vegas

89121

Pfizer Investigational Site, Las Vegas

89144

Pfizer Investigational Site, Las Vegas

90045

Pfizer Investigational Site, Los Angeles

91206

Pfizer Investigational Site, Glendale

92653

Pfizer Investigational Site, Laguna Hills

Pfizer Investigational Site, Laguna Woods

97701

Pfizer Investigational Site, Bend

06001

Pfizer Investigational Site, Avon

06416

Pfizer Investigational Site, Cromwell

06082

Pfizer Investigational Site, Enfield

06030

Pfizer Investigational Site, Farmington

06032

Pfizer Investigational Site, Farmington

06033

Pfizer Investigational Site, Glastonbury

06102

Pfizer Investigational Site, Hartford

06106

Pfizer Investigational Site, Hartford

06067

Pfizer Investigational Site, Rocky Hill

06095

Pfizer Investigational Site, Windsor

V1Y 1T2

Pfizer Investigational Site, Kelowna

V1Y 3C8

Pfizer Investigational Site, Kelowna

V1Y 4V5

Pfizer Investigational Site, Kelowna

V6Z 1Y6

Pfizer Investigational Site, Vancouver

L1S 2J4

Pfizer Investigational Site, Ajax

L1S 2J5

Pfizer Investigational Site, Ajax

L1S 7K8

Pfizer Investigational Site, Ajax

K7L 2V7

Pfizer Investigational Site, Kingston

K7L 5G2

Pfizer Investigational Site, Kingston

M1E 4B9

Pfizer Investigational Site, Scarborough Village

M3M 2C2

Pfizer Investigational Site, Toronto

M5T 2S8

Pfizer Investigational Site, Toronto

M9N 1N8

Pfizer Investigational Site, Weston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00650039 - Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction | Biotech Hunter | Biotech Hunter