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

Condition(s) targeted: Pain

Intervention: Parecoxib Sodium/Valdecoxib (Drug); Placebo/Valdecoxib (Drug); Placebo/Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

Rate of supplemental analgesia consumed

Vital signs

Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8)

Opioid-related Symptoms Distress Scale (OR-SDS)

Time to last Patient Controlled Analgesia (PCA) dose

Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge)

Combined incidence of the number of patients with specific confirmed CRAEs in categories of cardiovascular thromboembolic CRAEs, renal CRAEs, upper gastrointestinal ulcer CRAEs, and wound healing complication CRAEs

Adverse events

Serious adverse events

Clinical laboratory assessments

Peak Pain Intensity (PPI) of sternotomy alone and overall body pain

Patient's and Physician's Global Evaluation of Study Medication

Modified Brief Pain Inventory-short form (mBPI-sf)

SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24)

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

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:

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

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

Starting date: January 2003
Ending date: January 2004
Last updated: March 7, 2008