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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 29, 2005

Last Updated Date

August 13, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Evaluation of efficacy assessments based on pain intensity (VAS) and on Pain relief (PR).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00139607 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Parecoxib In Post Surgery (Hemicolectomy) Pain

Official Title ^ICMJE

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

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

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Colectomy

Intervention ^ICMJE

Drug: Paracoxib

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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);

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00139607

Other Study ID Numbers ^ICMJE

PARA-0505-079, A3481022

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

August 2009

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

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