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
  Purpose

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 Intervention Phase
Colectomy
Drug: Paracoxib
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: September 2002
Estimated Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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);
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00139607     History of Changes
Other Study ID Numbers: PARA-0505-079, A3481022
Study First Received: August 29, 2005
Last Updated: August 13, 2009
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on April 15, 2014