Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy
NCT ID: NCT01290744
Last Updated: 2015-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2010-08-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo group
These patients will receive placebo for 12 months after completion of MDT.
Placebo
Daily for 12 months
Clofazimine for 12 months after MDT
Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.
Clofazimine
Clofazimine 100mg daily for 12 months after completion of MDT.
Interventions
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Clofazimine
Clofazimine 100mg daily for 12 months after completion of MDT.
Placebo
Daily for 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MB leprosy
* Pretreatment BI of 4 or more at any site
* Consent
Exclusion Criteria
* Refusal of informed consent
15 Years
70 Years
ALL
No
Sponsors
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Paul Saunderson
OTHER
Responsible Party
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Paul Saunderson
Scientific Director
Principal Investigators
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Marivic Balagon, MD
Role: PRINCIPAL_INVESTIGATOR
LWM
Locations
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Cebu Skin Clinic
Cebu, Vesayas, Philippines
Countries
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Other Identifiers
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LWM-2010-ENL
Identifier Type: -
Identifier Source: org_study_id
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