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Parecoxib In Post Surgery (Hemicolectomy) Pain

This study has been terminated.
(Please see detailed description for termination reason.)
Information provided by:
Pfizer Identifier:
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 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
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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.
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug: Paracoxib
Not Provided
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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);
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
PARA-0505-079, A3481022
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Study Director: Pfizer Call Center Pfizer
August 2009

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