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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Other: Placebo/Placebo; Drug: Placebo/Valdecoxib; Drug: Parecoxib Sodium/Valdecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00636064

PARA-0505-071

A3481015

Details and patient eligibility

About

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

Enrollment: 1,671 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,671 participants in 3 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Parecoxib Sodium/Valdecoxib

B

Experimental group

Treatment:

Drug: Placebo/Valdecoxib

C

Experimental group

Treatment:

Other: Placebo/Placebo