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Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)

NCT00128414 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-02-16

No results posted yet for this study

Summary

The purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode).

Conditions

  • Pericarditis
  • Recurrence

Interventions

DRUG

Colchicine (for 6 months)

colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients \<70 kg or intolerant to the highest dose.

DRUG

Placebo

Tablets identical in colour, shape, and taste were provided in blister packs.

Sponsors & Collaborators

  • Azienda Sanitaria Locale 3, Torino

    lead OTHER

Principal Investigators

  • Rita TRINCHERO, MD · Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino

  • Massimo Imazio, MD · Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.

  • Massimo Imazio, MD · Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2009-04-30
Completion
2010-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT00128414 on ClinicalTrials.gov