Status:
UNKNOWN
Montelukast in ENL Reaction
Lead Sponsor:
The Leprosy Mission Bangladesh
Conditions:
Erythema Nodosum Leprosum
Leprosy
Eligibility:
All Genders
15-65 years
Phase:
NA
Brief Summary
Objective of the trial is to assess the safety and efficacy of Montelukast in treatment of Erythema Nodosum leprosum (ENL) reaction in multibacillary leprosy patients either in combination with predni...
Detailed Description
Leprosy is still a common medical problem in many countries including Bangladesh, and currently there are at least 3500 leprosy patients in this country at risk of ENL reaction, which is a distressing...
Eligibility Criteria
Inclusion
- MB leprosy
- ENL reaction
- age 15-65
- weight \>35kg
- patient willing to participate,including agrees to investigations and admission
- adequate past records
- no steroid received in past 4 weeks
Exclusion
- pregnant or breast feeding
- other active serious infection
- history of intolerance to concerned drug
- known or suspected immunodeficiency
- needs high dose steroid for other condition
- recent new nerve funcion impairment
- recent hepatitis or impaired liver function
- thrombocytopenia, moderate or severe renal impairment
- received high dose clofazimine in past 3 months
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
End Date :
June 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00406861
Start Date
December 1 2006
End Date
June 1 2009
Last Update
December 4 2006
Active Locations (1)
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1
Danish Bangladesh Leprosy Mission Hospital
Nilphamari, Nilphamari, Bangladesh, 5300