Parecoxib In Post Surgery (Hemicolectomy) Pain

This study has been terminated.
(Please see detailed description for termination reason.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139607
First received: August 29, 2005
Last updated: August 13, 2009
Last verified: August 2009

August 29, 2005
August 13, 2009
September 2002
Not Provided
Evaluation of efficacy assessments based on pain intensity (VAS) and on Pain relief (PR).
Same as current
Complete list of historical versions of study NCT00139607 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Parecoxib In Post Surgery (Hemicolectomy) Pain
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

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colectomy
Drug: Paracoxib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
January 2005
Not Provided

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);
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00139607
PARA-0505-079, A3481022
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP