Parecoxib In Post Surgery (Hemicolectomy) Pain

NCT ID: NCT00139607

Last Updated: 2009-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2005-01-31

Brief Summary

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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

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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.

Conditions

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Colectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Paracoxib

Intervention Type DRUG

Eligibility Criteria

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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);
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Biella, , Italy

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Siena, , Italy

Site Status

Countries

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Italy

Related Links

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Other Identifiers

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A3481022

Identifier Type: -

Identifier Source: secondary_id

PARA-0505-079

Identifier Type: -

Identifier Source: org_study_id

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