Parecoxib In Post Surgery (Hemicolectomy) Pain

Phase 3TerminatedNCT00139607

Pfizer60 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colectomy

Interventions

ParacoxibDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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);

Locations (3)

Pfizer Investigational Site

Biella, Italy

Pfizer Investigational Site

Milan, Italy

Pfizer Investigational Site

Siena, Italy

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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