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

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Parecoxib Sodium/Valdecoxib; Drug: Placebo/Valdecoxib; Other: Placebo/Placebo

• Registration Number: NCT00636064
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study Completion: 2004-01
• Status Verified: 2008-03
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-14
• Last Update Submitted: 2008-10-09
• Last Update Posted: 2008-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1671

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Parecoxib Sodium/Valdecoxib	-
B	Placebo/Valdecoxib	-
C	Placebo/Placebo	-

Primary Outcome Measures

Name	Time	Method
Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE)	Day 30

Secondary Outcome Measures

Name	Time	Method
Adverse events	Day 30
Serious adverse events	Day 30
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	Day 30
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	Day 30
Rate of supplemental analgesia consumed	Days 1-10
Vital signs	Day 30
Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8)	Day 1
Opioid-related Symptoms Distress Scale (OR-SDS)	Days 1-10
Time to last Patient Controlled Analgesia (PCA) dose
Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge)
Clinical laboratory assessments	Day 30
Peak Pain Intensity (PPI) of sternotomy alone and overall body pain	Days 1-10
Patient's and Physician's Global Evaluation of Study Medication	At time of transition from intravenous to oral medication and final visit/early termination
Modified Brief Pain Inventory-short form (mBPI-sf)	Days 1-10
SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24)	Days 1-10

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Oxford, United Kingdom