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Montelukast in ENL Reaction

NCT00406861 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2006-12-04

No results posted yet for this study

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

Conditions

  • Erythema Nodosum Leprosum
  • Leprosy

Interventions

DRUG

montelukast in treatment of ENL reaction

Sponsors & Collaborators

  • The Leprosy Mission Bangladesh

    lead OTHER

Principal Investigators

  • Abdul H Salim, MBBS · Damien Foundation Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Completion
2009-06-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00406861 on ClinicalTrials.gov