Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Vermont
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Argentina
State/province [28] 0 0
Pcia. de Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Buenos Aires
Country [30] 0 0
Austria
State/province [30] 0 0
Graz
Country [31] 0 0
Belgium
State/province [31] 0 0
Brussel
Country [32] 0 0
Belgium
State/province [32] 0 0
Bruxelles
Country [33] 0 0
Belgium
State/province [33] 0 0
Edegem
Country [34] 0 0
Belgium
State/province [34] 0 0
Genk
Country [35] 0 0
Belgium
State/province [35] 0 0
Liege
Country [36] 0 0
Canada
State/province [36] 0 0
Alberta
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Manitoba
Country [39] 0 0
Canada
State/province [39] 0 0
Nova Scotia
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Canada
State/province [42] 0 0
Saskatchewan
Country [43] 0 0
Colombia
State/province [43] 0 0
Cundinamarca
Country [44] 0 0
Colombia
State/province [44] 0 0
Santander
Country [45] 0 0
Colombia
State/province [45] 0 0
Valle
Country [46] 0 0
Colombia
State/province [46] 0 0
Bogota
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Ceske Budejovice
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Prague 5
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Prague
Country [50] 0 0
Denmark
State/province [50] 0 0
Kobenhavn
Country [51] 0 0
Denmark
State/province [51] 0 0
Odense C
Country [52] 0 0
Finland
State/province [52] 0 0
Kuopio
Country [53] 0 0
Finland
State/province [53] 0 0
Oulu
Country [54] 0 0
Finland
State/province [54] 0 0
Turku
Country [55] 0 0
Germany
State/province [55] 0 0
Aachen
Country [56] 0 0
Germany
State/province [56] 0 0
Bonn
Country [57] 0 0
Germany
State/province [57] 0 0
Giessen
Country [58] 0 0
Germany
State/province [58] 0 0
Goettingen
Country [59] 0 0
Germany
State/province [59] 0 0
Hamburg
Country [60] 0 0
Germany
State/province [60] 0 0
Heidelberg
Country [61] 0 0
Germany
State/province [61] 0 0
Kassel
Country [62] 0 0
Germany
State/province [62] 0 0
Kiel
Country [63] 0 0
Germany
State/province [63] 0 0
Muenchen
Country [64] 0 0
Germany
State/province [64] 0 0
Muenster
Country [65] 0 0
Ireland
State/province [65] 0 0
Dublin
Country [66] 0 0
Israel
State/province [66] 0 0
Beer Sheva
Country [67] 0 0
Israel
State/province [67] 0 0
Haifa
Country [68] 0 0
Israel
State/province [68] 0 0
Holon
Country [69] 0 0
Israel
State/province [69] 0 0
Jerusalem
Country [70] 0 0
Israel
State/province [70] 0 0
Petach-Tikva
Country [71] 0 0
Israel
State/province [71] 0 0
Ramat-Gan
Country [72] 0 0
Israel
State/province [72] 0 0
Rehovot
Country [73] 0 0
Israel
State/province [73] 0 0
Tel Aviv
Country [74] 0 0
Israel
State/province [74] 0 0
Tel Hashomer
Country [75] 0 0
Italy
State/province [75] 0 0
Firenze
Country [76] 0 0
Italy
State/province [76] 0 0
Milano
Country [77] 0 0
Italy
State/province [77] 0 0
Pavia
Country [78] 0 0
Italy
State/province [78] 0 0
Pisa
Country [79] 0 0
Mexico
State/province [79] 0 0
DF
Country [80] 0 0
Mexico
State/province [80] 0 0
Mexico DF
Country [81] 0 0
Mexico
State/province [81] 0 0
Mexico, DF
Country [82] 0 0
Netherlands
State/province [82] 0 0
Breda
Country [83] 0 0
Netherlands
State/province [83] 0 0
Eindhoven
Country [84] 0 0
Netherlands
State/province [84] 0 0
Zwolle
Country [85] 0 0
Norway
State/province [85] 0 0
Feiring
Country [86] 0 0
Poland
State/province [86] 0 0
Bialystok
Country [87] 0 0
Poland
State/province [87] 0 0
Krakow
Country [88] 0 0
Poland
State/province [88] 0 0
Poznan
Country [89] 0 0
Poland
State/province [89] 0 0
Szczecin
Country [90] 0 0
Poland
State/province [90] 0 0
Warszawa
Country [91] 0 0
Romania
State/province [91] 0 0
Bucharest
Country [92] 0 0
Romania
State/province [92] 0 0
Bucuresti
Country [93] 0 0
Romania
State/province [93] 0 0
Cluj-Napoca
Country [94] 0 0
Romania
State/province [94] 0 0
Timisoara
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Moscow
Country [96] 0 0
Singapore
State/province [96] 0 0
Singapore
Country [97] 0 0
Slovakia
State/province [97] 0 0
Bratislava
Country [98] 0 0
Slovakia
State/province [98] 0 0
Kosice
Country [99] 0 0
South Africa
State/province [99] 0 0
Free State
Country [100] 0 0
South Africa
State/province [100] 0 0
Gauteng Province
Country [101] 0 0
South Africa
State/province [101] 0 0
Gauteng
Country [102] 0 0
South Africa
State/province [102] 0 0
KwaZulu Natal
Country [103] 0 0
South Africa
State/province [103] 0 0
Pretoria
Country [104] 0 0
South Africa
State/province [104] 0 0
Western Cape
Country [105] 0 0
South Africa
State/province [105] 0 0
Bloemfontein
Country [106] 0 0
Spain
State/province [106] 0 0
Barcelona
Country [107] 0 0
Spain
State/province [107] 0 0
Madrid
Country [108] 0 0
Spain
State/province [108] 0 0
Valencia
Country [109] 0 0
Sweden
State/province [109] 0 0
Orebro
Country [110] 0 0
Sweden
State/province [110] 0 0
Stockholm
Country [111] 0 0
Sweden
State/province [111] 0 0
Uppsala
Country [112] 0 0
Switzerland
State/province [112] 0 0
Bern
Country [113] 0 0
Switzerland
State/province [113] 0 0
Geneve 14
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Edinburgh
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Liverpool
Country [116] 0 0
United Kingdom
State/province [116] 0 0
London
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Middlesbrough
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Oxford

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