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Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion

NCT00247052 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2009-08-03

No results posted yet for this study

Summary

The aim of the sudy is to evaluate, through clinical, biological and transthoracic echocardiography follow up, the evolution of post operative (cardiac surgery) pericardial effusion and mostly to evaluate the efficiency of a non steroidal anti inflammatory (NSAID) drug (diclofenac)for this indication.

Conditions

  • Pericardial Effusion

Interventions

DRUG

diclofenac

diclofenac 50 mg bid versus placebo bid

DRUG

diclofenac

diclofenac 100 mg per day for 14 days

DRUG

matching placebo

Sponsors & Collaborators

  • CLIPA

    collaborator UNKNOWN

  • Clinact

    collaborator OTHER

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Philippe Meurin, MD · Les grands Prés; 27 rue Sainte Christine 77174 , Villeneuve Saint Denis, France

  • Philippe Meurin, MD · Les Grands Prés

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-12-31
Completion
2009-02-28

Countries

  • France

Study Locations

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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 NCT00247052 on ClinicalTrials.gov