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
NCT00636064
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- 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
- 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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Descriptive Information | ||||
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Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 1671 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, Germany, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00636064 | |||
Other Study ID Numbers ICMJE | PARA-0505-071 A3481015 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |