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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00636064




Registration number
NCT00636064
Ethics application status
Date submitted
7/03/2008
Date registered
14/03/2008
Date last updated
10/10/2008

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
A3481015
Secondary ID [2] 0 0
PARA-0505-071
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Parecoxib Sodium/Valdecoxib
Treatment: Drugs - Placebo/Valdecoxib
Other interventions - Placebo/Placebo

Placebo comparator: A -

Experimental: B -

Experimental: C -


Treatment: Drugs: 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.

Treatment: Drugs: 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 interventions: 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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE)
Timepoint [1] 0 0
Day 30
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Day 30
Secondary outcome [2] 0 0
Rate of supplemental analgesia consumed
Timepoint [2] 0 0
Days 1-10
Secondary outcome [3] 0 0
Vital signs
Timepoint [3] 0 0
Day 30
Secondary outcome [4] 0 0
Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8)
Timepoint [4] 0 0
Day 1
Secondary outcome [5] 0 0
Opioid-related Symptoms Distress Scale (OR-SDS)
Timepoint [5] 0 0
Days 1-10
Secondary outcome [6] 0 0
Time to last Patient Controlled Analgesia (PCA) dose
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge)
Timepoint [7] 0 0
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Day 30
Secondary outcome [9] 0 0
Adverse events
Timepoint [9] 0 0
Day 30
Secondary outcome [10] 0 0
Serious adverse events
Timepoint [10] 0 0
Day 30
Secondary outcome [11] 0 0
Clinical laboratory assessments
Timepoint [11] 0 0
Day 30
Secondary outcome [12] 0 0
Peak Pain Intensity (PPI) of sternotomy alone and overall body pain
Timepoint [12] 0 0
Days 1-10
Secondary outcome [13] 0 0
Patient's and Physician's Global Evaluation of Study Medication
Timepoint [13] 0 0
At time of transition from intravenous to oral medication and final visit/early termination
Secondary outcome [14] 0 0
Modified Brief Pain Inventory-short form (mBPI-sf)
Timepoint [14] 0 0
Days 1-10
Secondary outcome [15] 0 0
SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24)
Timepoint [15] 0 0
Days 1-10

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2004
Sample size
Target
Accrual to date
Final
1671
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Auchenflower
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Ashford
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Clayton
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
5035 - Ashford
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00636064
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00636064