Parecoxib In Post Surgery (Hemicolectomy) Pain

Colectomy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00139607
• Other study ID #: PARA-0505-079
• Secondary ID: A3481022
• Status: Terminated
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: August 13, 2009
• Start date: September 2002
• Est. completion date: January 2005

Study information

• Verified date: August 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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);

Study Design

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

Related Conditions & MeSH terms

• Colectomy

Intervention

Drug:
• Paracoxib

Locations

Country	Name	City	State
Italy	Pfizer Investigational Site	Biella
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of efficacy assessments based on pain intensity (VAS) and on Pain relief (PR).
Secondary	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

External Links

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