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Modulation of the Surgical Inflammatory Response by Etoricoxib

NCT00746720 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-12-14

No results posted yet for this study

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.

Conditions

  • Pain
  • Osteoarthritis, Hip
  • Postoperative Pain

Interventions

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

Sponsors & Collaborators

  • HELIOS Kliniken GmbH

    collaborator UNKNOWN

  • Rush University Medical Center

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Kay Brune, MD, PhD · University of Erlangen-Nürnberg

  • Josef Zacher, MD, PhD · Helios Klinikum Berlin-Buch

  • Martin Fromm, MD, PhD · University of Erlangen-Nürnberg

  • Asokumar Buvanendran, MD · Rush University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-07-31
Completion
2010-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00746720 on ClinicalTrials.gov