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Parecoxib In Post Surgery (Hemicolectomy) Pain

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ClinicalTrials.gov Identifier: NCT00139607
Recruitment Status : Terminated (Please see detailed description for termination reason.)
First Posted : August 31, 2005
Last Update Posted : August 14, 2009
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Colectomy Drug: Paracoxib Phase 3

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  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2002
Study Completion Date : January 2005



Primary Outcome Measures :
  1. Evaluation of efficacy assessments based on pain intensity (VAS) and on Pain relief (PR).

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139607


Locations
Italy
Pfizer Investigational Site
Biella, Italy, 13051
Pfizer Investigational Site
Milano, Italy, 20123
Pfizer Investigational Site
Siena, Italy, 53100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00139607     History of Changes
Other Study ID Numbers: PARA-0505-079
A3481022
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: August 14, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Parecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents