UnknownNot Applicable

Montelukast in ENL Reaction

Bangladesh60 participantsStarted 2006-12

Plain-language 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

Who can participate

Age range15 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

decrease in ENL score

absence of new nerve function impairment

incidence of adverse effects

Trial details

NCT IDNCT00406861

SponsorThe Leprosy Mission Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Contact for this trial

Abdul H Salim, MBBS

880173011135 dfsalim@citechco.net

View on ClinicalTrials.gov More Erythema Nodosum Leprosum trials