Parecoxib In Post Surgery (Hemicolectomy) Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00139607
• Date of registration: 29/08/2005
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Parecoxib In Post Surgery (Hemicolectomy) Pain
• Scientific 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
• Date of first enrolment: September 2002
• Target sample size: 60
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00139607
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Italy

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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);



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Colectomy

Intervention(s)

Drug: Paracoxib

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

PARA-0505-079

A3481022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors