Status:
TERMINATED
Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy
Lead Sponsor:
Pfizer
Conditions:
Pain, Postoperative
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end...
Detailed Description
The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010. The decision to terminate the trial was not based on any safety concerns.
Eligibility Criteria
Inclusion
- The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,\<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator.
- The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia.
Exclusion
- The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
- The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00346268
Start Date
December 1 2006
End Date
September 1 2010
Last Update
October 28 2011
Active Locations (4)
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1
Pfizer Investigational Site
Cologne, Germany, 50924
2
Pfizer Investigational Site
Essen, Germany, 45136
3
Pfizer Investigational Site
Heidelberg, Germany, 69121
4
Pfizer Investigational Site
Reutlingen, Germany, 72764