PainPhase 3NCT00636064
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
A Phase 3 study testing Parecoxib Sodium/Valdecoxib in people with Pain, run by Pfizer at 206 sites in 27 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Parecoxib Sodium/Valdecoxib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,671 participants
- Where
- 206 sitesin 27 countries
- Study dates
- Jan 2003to Jan 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
206 sites in 27 countries.
206 sites in 27 countries
United States84 sites
Pfizer Investigational Site
Altoona, Pennsylvania, 16601
Pfizer Investigational Site
Amarillo, Texas, 79106
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Anaheim, California, 92805
Pfizer Investigational Site
Annandale, Virginia, 22003
Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Augusta, Georgia, 30901
Pfizer Investigational Site
Baltimore, Maryland, 21215
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Brandon, Florida, 33511
Pfizer Investigational Site
Burlington, Vermont, 05401
Pfizer Investigational Site
Cambridge, Massachusetts, 02138
Pfizer Investigational Site
Charleston, South Carolina, 29401
Pfizer Investigational Site
Charleston, South Carolina, 29406
Pfizer Investigational Site
Charleston, South Carolina, 29424
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45236
Pfizer Investigational Site
Clearwater, Florida, 33756
Pfizer Investigational Site
Dayton, Ohio, 45408
Pfizer Investigational Site
Dayton, Ohio, 45414
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Elkhorn, Wisconsin, 53121
Pfizer Investigational Site
Fairhope, Alabama, 36532
Pfizer Investigational Site
Falls Church, Virginia, 22042
Pfizer Investigational Site
Fayetteville, Arkansas, 72703
Pfizer Investigational Site
Fort Collins, Colorado, 80524
Pfizer Investigational Site
Fort Collins, Colorado, 80528
Pfizer Investigational Site
Fort Wayne, Indiana, 46804
Pfizer Investigational Site
Fort Worth, Texas, 76107-2699
Pfizer Investigational Site
Fort Worth, Texas, 76107
Pfizer Investigational Site
Fredericksburg, Virginia, 22401
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Hudson, Florida, 34667
Pfizer Investigational Site
Iowa City, Iowa, 52242
Pfizer Investigational Site
Irving, Texas, 75061
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Kansas City, Kansas, 66160
Pfizer Investigational Site
Livonia, Michigan, 48150
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Los Angeles, California, 90095-1778
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Melbourne, Florida, 32901-3276
Pfizer Investigational Site
Melbourne, Florida, 32901
Pfizer Investigational Site
Memphis, Tennessee, 38120
Pfizer Investigational Site
Milwaukee, Wisconsin, 53215
Pfizer Investigational Site
Mobile, Alabama, 36602
Pfizer Investigational Site
Mobile, Alabama, 36604
Pfizer Investigational Site
Mobile, Alabama, 36607
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Muskegon, Michigan, 49444
Pfizer Investigational Site
New Haven, Connecticut, 06504
Pfizer Investigational Site
New Haven, Connecticut, 06520
Pfizer Investigational Site
New York, New York, 10029
Pfizer Investigational Site
Norfolk, Virginia, 23507
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Pensacola, Florida, 32504
Pfizer Investigational Site
Pensacola, Florida, 32514
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15212
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15224
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Rochester, New York, 14621
Pfizer Investigational Site
Royal Oak, Michigan, 48073
Pfizer Investigational Site
Sacramento, California, 95819
Pfizer Investigational Site
Sacramento, California, 95825
Pfizer Investigational Site
Salisbury, Maryland, 21801
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
San Francisco, California, 94118-3110
Pfizer Investigational Site
San Francisco, California, 94143-0648
Pfizer Investigational Site
Sandusky, Ohio, 44870
Pfizer Investigational Site
Santa Rosa, California, 95403
Pfizer Investigational Site
Santa Rosa, California, 95404
Pfizer Investigational Site
Sarasota, Florida, 34239
Pfizer Investigational Site
Springdale, Arkansas, 72764
Pfizer Investigational Site
St. Petersburg, Florida, 33709
Pfizer Investigational Site
Stanford, California, 94305
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Takoma Park, Maryland, 20912
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
Towson, Maryland, 21204
Pfizer Investigational Site
Tucson, Arizona, 85724
Pfizer Investigational Site
Tulsa, Oklahoma, 74104
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Canada15 sites
Pfizer Investigational Site
Edmonton, Alberta, T6G 2B7
Pfizer Investigational Site
Fleurimont, Quebec, J1H 5N4
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 3A7
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7
Pfizer Investigational Site
Kingston, Ontario, K7L 5G2
Pfizer Investigational Site
London, Ontario, N6A 5A5
Pfizer Investigational Site
Montreal, Quebec, H1T 1C8
Pfizer Investigational Site
Montreal, Quebec, H3A 1A1
Pfizer Investigational Site
Regina, Saskatchewan, S4P 0W5
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7N 0W8
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, M5G 2C4
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1M9
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 1Y6
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9
Israel12 sites
Pfizer Investigational Site
Beersheba
Pfizer Investigational Site
Haifa, 34362
Pfizer Investigational Site
Haifa
Pfizer Investigational Site
Holon, 58100
Pfizer Investigational Site
Jerusalem, 91004
Pfizer Investigational Site
Jerusalem, 91031
Pfizer Investigational Site
Jerusalem, 91120
Pfizer Investigational Site
Petah Tikva, 49261
Pfizer Investigational Site
Ramat Gan
Pfizer Investigational Site
Rehovot
Pfizer Investigational Site
Tel Aviv
Pfizer Investigational Site
Tel HaShomer, 52651
South Africa12 sites
Pfizer Investigational Site
Bloemfontein, Free State
Pfizer Investigational Site
Bloemfontein, 9300
Pfizer Investigational Site
Durban, KwaZulu-Natal
Pfizer Investigational Site
Johannesburg, Gauteng
Pfizer Investigational Site
Les Marais, Pretoria, 0084
Pfizer Investigational Site
Parow, Western Cape, 7500
Pfizer Investigational Site
Pretoria, Gauteng, 0002
Pfizer Investigational Site
Pretoria, Gauteng, 0084
Pfizer Investigational Site
Pretoria, Gauteng, 0140
Pfizer Investigational Site
Pretoria, Gauteng
Pfizer Investigational Site
Pretoria, 0002
Pfizer Investigational Site
Pretoria, 0040
Germany10 sites
Pfizer Investigational Site
Aachen, 52074
Pfizer Investigational Site
Bonn, 53105
Pfizer Investigational Site
Giessen, 35385
Pfizer Investigational Site
Göttingen, 37075
Pfizer Investigational Site
Hamburg, 20251
Pfizer Investigational Site
Heidelberg, 69120
Pfizer Investigational Site
Kassel, 34125
Pfizer Investigational Site
Kiel, 24105
Pfizer Investigational Site
München, 81377
Pfizer Investigational Site
Münster, 48149
Czechia6 sites
Pfizer Investigational Site
České Budějovice, 370 87
Pfizer Investigational Site
Prague, 100 34
Pfizer Investigational Site
Prague, 128 00
Pfizer Investigational Site
Prague, 14220
Pfizer Investigational Site
Prague, 150 00
Pfizer Investigational Site
Prague, 15500
United Kingdom6 sites
Pfizer Investigational Site
Edinburgh, Eh3 9YW
Pfizer Investigational Site
Liverpool
Pfizer Investigational Site
London, E2 9JX
Pfizer Investigational Site
London, SE1 7EH
Pfizer Investigational Site
Middlesbrough, TS4 3BW
Pfizer Investigational Site
Oxford, OX3 9DU
Belgium5 sites
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Brussels, 1090
Pfizer Investigational Site
Edegem, 2650
Pfizer Investigational Site
Genk, 3600
Pfizer Investigational Site
Liège, B-4000
Mexico5 sites
Pfizer Investigational Site
Mexico City, Mexico City, 03100
Pfizer Investigational Site
Mexico City, Mexico City, 06720
Pfizer Investigational Site
Mexico City, Mexico City, 14050
Pfizer Investigational Site
Mexico City, Mexico DF, 07760
Pfizer Investigational Site
Mexico City, Mexico, DF, 14000
Poland5 sites
Pfizer Investigational Site
Bialystok, 15-276
Pfizer Investigational Site
Krakow, 31-202
Pfizer Investigational Site
Poznan, 61-848
Pfizer Investigational Site
Szczecin, 70-111
Pfizer Investigational Site
Warsaw, 02-097
Romania5 sites
Pfizer Investigational Site
Bucharest, 7000
Pfizer Investigational Site
Bucharest, 71406
Pfizer Investigational Site
Bucharest, 771181
Pfizer Investigational Site
Cluj-Napoca, 3400
Pfizer Investigational Site
Timișoara, 1900
Argentina4 sites
Pfizer Investigational Site
Buenos Aires, 1118
Pfizer Investigational Site
Buenos Aires, 1416
Pfizer Investigational Site
Buenos Aires, C1405DCS
Pfizer Investigational Site
Morón, Pcia. de Buenos Aires, 1708
Colombia4 sites
Pfizer Investigational Site
Bogota, Cundinamarca, 000
Pfizer Investigational Site
Bogotá
Pfizer Investigational Site
Cali, Valle del Cauca Department, Nap
Pfizer Investigational Site
Floridablanca, Santander Department, 000
Finland4 sites
Pfizer Investigational Site
Kuopio, 70211
Pfizer Investigational Site
Kuopio
Pfizer Investigational Site
Oulu
Pfizer Investigational Site
Turku, FIN-20520
Italy4 sites
Pfizer Investigational Site
Florence, 50134
Pfizer Investigational Site
Milan, 20138
Pfizer Investigational Site
Pavia, 27100
Pfizer Investigational Site
Pisa, 56125
Spain4 sites
Pfizer Investigational Site
Barcelona, 08025
Pfizer Investigational Site
Barcelona, 08907
Pfizer Investigational Site
Madrid, 28046
Pfizer Investigational Site
Valencia, 46010
Australia3 sites
Pfizer Investigational Site
Ashford, South Australia, 5035
Pfizer Investigational Site
Auchenflower, Queensland, 4066
Pfizer Investigational Site
Clayton, Victoria, 3168
Netherlands3 sites
Pfizer Investigational Site
Breda, 4836 AE
Pfizer Investigational Site
Eindhoven, 5623 EJ
Pfizer Investigational Site
Zwolle, 8011 JW
Sweden3 sites
Pfizer Investigational Site
Örebro, SE-701 85
Pfizer Investigational Site
Stockholm, 171 76
Pfizer Investigational Site
Uppsala, SE 751 85
Denmark2 sites
Pfizer Investigational Site
Copenhagen, 2100
Pfizer Investigational Site
Odense C, 5000
Russia2 sites
Pfizer Investigational Site
Moscow, 119992
Pfizer Investigational Site
Moscow, 123182
Slovakia2 sites
Pfizer Investigational Site
Bratislava, 833 48
Pfizer Investigational Site
Košice, 040-11
Switzerland2 sites
Pfizer Investigational Site
Bern, 3010
Pfizer Investigational Site
Geneva, 1211
About this study
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
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
- Conditions
- Pain
- Being tested
- Parecoxib Sodium/Valdecoxib, Placebo/Valdecoxib, Placebo/Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parecoxib Sodium/ValdecoxibDrug
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.
Placebo/ValdecoxibDrug
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.
Placebo/PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Parecoxib Sodium/Valdecoxib |
| B | Experimental | Not described Receives: Drug: Placebo/Valdecoxib |
| C | Experimental | Not described Receives: Other: Placebo/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE)
Measured: Day 30
Secondary outcomes (15)
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
Measured: Day 30
Rate of supplemental analgesia consumed
Measured: Days 1-10
Vital signs
Measured: Day 30
Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8)
Measured: Day 1
Opioid-related Symptoms Distress Scale (OR-SDS)
Measured: 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)
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
Measured: Day 30
Adverse events
Measured: Day 30
Serious adverse events
Measured: Day 30
Clinical laboratory assessments
Measured: Day 30
Peak Pain Intensity (PPI) of sternotomy alone and overall body pain
Measured: Days 1-10
Patient's and Physician's Global Evaluation of Study Medication
Measured: At time of transition from intravenous to oral medication and final visit/early termination
Modified Brief Pain Inventory-short form (mBPI-sf)
Measured: Days 1-10
SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24)
Measured: Days 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startJan 2003
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636064
- Sponsor's protocol ID
- PARA-0505-071
- Other IDs
- A3481015
- Status last verified
- Mar 2008
- First submitted
- 7 Mar 2008
- Last updated
- 10 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00636064
- Acronym / sponsor ID
- PARA-0505-071
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,671 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Jan 2004 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Parecoxib Sodium/Valdecoxib |
| B | Experimental | Drug: Placebo/Valdecoxib |
| C | Experimental | Other: Placebo/Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parecoxib Sodium/ValdecoxibParecoxib 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. | Drug | A |
| Placebo/ValdecoxibPatients 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. | Drug | B |
| Placebo/PlaceboPatients 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. | Other | C |
Primary outcome
Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE)
Time frame: Day 30
15 secondary outcomes
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
Time frame: Day 30
Rate of supplemental analgesia consumed
Time frame: Days 1-10
Vital signs
Time frame: Day 30
Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8)
Time frame: Day 1
Opioid-related Symptoms Distress Scale (OR-SDS)
Time frame: 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)
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
Time frame: Day 30
Adverse events
Time frame: Day 30
Serious adverse events
Time frame: Day 30
Clinical laboratory assessments
Time frame: Day 30
Peak Pain Intensity (PPI) of sternotomy alone and overall body pain
Time frame: Days 1-10
Patient's and Physician's Global Evaluation of Study Medication
Time frame: At time of transition from intravenous to oral medication and final visit/early termination
Modified Brief Pain Inventory-short form (mBPI-sf)
Time frame: Days 1-10
SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24)
Time frame: Days 1-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
206 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Parecoxib Sodium/Valdecoxib in people with Pain, run by Pfizer at 206 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 206 sites in United States, Canada, Israel, South Africa, Germany and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE) (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2008; AzTrials last refreshed its copy on 6 Nov 2026.