drugset / Trial / NCT00406861

Montelukast in ENL Reaction

NCT00406861

Unknown 60 enrolled The Leprosy Mission Bangladesh
RandomizedParallel-groupSingle-blindTreatment

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 prednisolone or alone. Hypothesis is that montelukast will reduce the severity of ENL reaction in Multibacillary leprosy patients without causing an unacceptably high incidence of adverse effects. Design is a multicentre hospital-based single-blind prospective trial for leprosy patients with ENL reaction. prior written consent will be taken from the patients who will undergo the trial. Endpoints are decrease in severity of ENL and absence of new nerve function impairment

Timeline

Start
2006-12
Primary completion
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Montelukast Other / unclassified 10 mg