- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00139607
Parecoxib In Post Surgery (Hemicolectomy) Pain
August 13, 2009 updated by: Pfizer
A Multicenter, Open Label, Pilot Study To Evaluate Analgesic Activity And Safety Of Parecoxib 40 Mg IV In Patients Undergoing Hemicolectomy, In The Optimal Management Of Acute Post-Operative Pain Of Surgical Patients
This is a phase III, multicenter, open label, pilot to evaluate the analgesic efficacy and safety of parecoxib 40 mg IV in the treatment of the pain following hemicolectomy in an optimal management of the surgical patient
Study Overview
Detailed Description
The study was terminated prematurely due to recruitment issues on 31 January 2006.
Safety concerns did not lead to the decision to terminate this study.
Study Type
Interventional
Enrollment
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Biella, Italy, 13051
- Pfizer Investigational Site
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Milano, Italy, 20123
- Pfizer Investigational Site
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Siena, Italy, 53100
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients hospitalised for resection of left/right colon;
- preoperative health graded as ASA <3.
Exclusion Criteria:
- patients with any type of metastatic cancer, particularly metastatic colon cancer;
- patients with familial adenomatous polyps (sporadic adenomatous polyps are accepted);
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Evaluation of efficacy assessments based on pain intensity (VAS) and on Pain relief (PR).
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Secondary Outcome Measures
Outcome Measure |
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Time between the first administration of parecoxib and the first request of morphine The total amount of morphine in the first 24 hours of treatment and the total amount of morphine given during the entire period of treatment with parecoxib
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Study Completion
January 1, 2005
Study Registration Dates
First Submitted
August 29, 2005
First Submitted That Met QC Criteria
August 29, 2005
First Posted (Estimate)
August 31, 2005
Study Record Updates
Last Update Posted (Estimate)
August 14, 2009
Last Update Submitted That Met QC Criteria
August 13, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- PARA-0505-079
- A3481022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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