Parecoxib In Post Surgery (Hemicolectomy) Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00139607
Recruitment Status : Terminated (Please see detailed description for termination reason.)
First Posted : August 31, 2005
Last Update Posted : August 14, 2009
Information provided by:

August 29, 2005
August 31, 2005
August 14, 2009
September 2002
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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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Paracoxib
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2005
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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);
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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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