Parecoxib In Post Surgery (Hemicolectomy) Pain
Phase 3
Terminated
- Conditions
- Colectomy
- Registration Number
- NCT00139607
- Lead Sponsor
- Pfizer
- Brief Summary
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
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluation of efficacy assessments based on pain intensity (VAS) and on Pain relief (PR).
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇮🇹Siena, Italy