Status:
TERMINATED
A Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery
Lead Sponsor:
Pfizer
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.
Detailed Description
This study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the pri...
Eligibility Criteria
Inclusion
- Male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg undergoing elective intra-peritoneal laparoscopic abdominal surgery
- American Society of Anaesthesiologists (ASA) Physical Status I-III
Exclusion
- Significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory, which would contraindicate participation in the study or interfere with interpretation of study results
- Active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known coagulation defect
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00651300
Start Date
April 1 2003
End Date
March 1 2004
Last Update
June 11 2009
Active Locations (8)
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1
Pfizer Investigational Site
Port Macquarie, New South Wales, Australia
2
Pfizer Investigational Site
Randwick, New South Wales, Australia, 2031
3
Pfizer Investigational Site
Westmead, New South Wales, Australia, 2145
4
Pfizer Investigational Site
Coopers Plain, Queensland, Australia, 4108