At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 859 enrolled

Drug / intervention

PB 6 doses - Rifampicin and Dapsone +3 moredrug

Likely dose

PB 6 doses - Rifampicin and Dapsone 600 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00669643

NCT00669643Phase 4Completed

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Independent Study to Establish the Efficacy of the Six Doses Uniform MDT Regimen (U-MDT) for Leprosy Patients

University of Brasilia·interventional·Posted Apr 30, 2008·Updated Jun 1, 2017

In Brief

A Phase 4 clinical trial evaluating PB 6 doses - Rifampicin and Dapsone, PB 6 doses - Rifampicin, Clofazimine and Dapsone, and 2 other interventions for Leprosy. Completed, enrolled 859 participants across 2 sites.

Detailed Summary

The purpose of this randomized trial is to verify if leprosy patients, despite of their classification, can be treated with the same regimen without compromising patient cure and acceptability of the treatment. At present, patients classified as multibacillary leprosy are treated for 12 months with three drugs, and patients classified as paucibacillary leprosy are treated for 6 months with two drugs. The study is going to test a unified regimen for paucibacillary and multibacillary patients by treating leprosy patients with three drugs for 6 doses.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLeprosy

CountriesBrazil

CollaboratorsConselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Science and Technology, Brazil, Ministry of Health, Brazil, Fundação Alfredo da Matta, Manaus, Brazil, Instituto de Dermatologia Dona Libania, Fortaleza, Brazil

Timeline

Phase 4CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2007

First PostedApr 2008

Primary CompletionSep 2012

Study CompletionDec 2016

TodayJul 2026

First PostedApr 30, 2008

Enrollment StartFeb 1, 2007

Primary CompletionSep 1, 2012

Study CompletionDec 31, 2016

TodayJul 2, 2026

Enrollment to primary: 5.6 yearsPosted 18.2 years ago

Interventions

PB 6 doses - Rifampicin and Dapsonedrug

Adult: 6 doses; 1 monthly supervised dose: 600 mg Rifampicin + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone; Children: 6 doses; 1 monthly supervised dose: 450 mg Rifampicin + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone

PB 6 doses - Rifampicin, Clofazimine and Dapsonedrug

Adult: 6 doses; 1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine; Children: 6 doses; 1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine

MB 12 doses - Rifampicin, Clofazimine and Dapsonedrug

Adult: 12 doses; 1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine; Children: 12 doses; 1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine

MB 6 doses - Rifampicin, Clofazimine and Dapsonedrug

Adult: 6 doses 1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine Children: 6 doses 1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine