Parecoxib In Post Surgery (Hemicolectomy) Pain

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00139607

Enrollment

Registered

2005-08-31

Start date

2002-09-30

Completion date

2005-01-31

Last updated

2009-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colectomy

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.

Interventions

DRUGParacoxib

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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);

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026