NCT00746720

Modulation of the Surgical Inflammatory Response by Etoricoxib

Modulation of the Surgical Inflammatory Response by Etoricoxib: Peripheral Versus Central

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the hypothesis that orally administered etoricoxib (COX-2) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS) and in the periphery in surgical patients and thus reduces pain and suffering.

Detailed description

This study will be a multiple centre, double-blind, placebo-controlled, randomized, parallel group study conducted in male and female adult patients undergoing elective primary single hip arthroplasty. In part 1 of the study 12 patients will be enrolled in the study and will be administrated 120 mg Etoricoxib or placebo orally on day one post surgery. The results from part 1 should help to adjust sampling time points (for blood, cerebrospinal fluid and hip drain fluid) if necessary. In part 2 of the study 40 patients will be enrolled and should receive 120 mg etoricoxib or placebo two hours before and 24 hours after surgery. Primary end points will be the inflammatory mediators on peripheral and central levels. After surgical manipulation we expect increased mediators on both sides. It will be investigated if the medication could reduce the mediators compared to placebo and if the effect is related to pharmacokinetic parameters.

Conditions

• Pain
• Osteoarthritis, Hip
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Etoricoxib 60 mg	film coated tablet 60 mg (orally), 120 mg (= 2 tablets a 60 mg) once daily, on day one post surgery
DRUG	Placebo for Etoricoxib 60 mg	film coated tablet (orally), two tablets once daily, on day one post surgery
DRUG	Etoricoxib 60 mg	film coated tablet (orally), 120 mg (= 2 tablets a 60 mg) once daily, two hours before and 24 hours after surgery
DRUG	Placebo for Etoricoxib 60 mg	film coated tablet (orally), 2 tablets once daily, two hours before and 24 hours after surgery

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-07-01
• Completion: 2010-12-01
• First posted: 2008-09-04
• Last updated: 2020-12-14

Locations

1 site across 1 country: Germany