NCT00406861

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 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 4, 2006

Status Verified

November 1, 2006

First QC Date

December 1, 2006

Last Update Submit

December 1, 2006

Conditions

Erythema Nodosum LeprosumLeprosy

Keywords

reactionENLleprosy

Outcome Measures

Primary Outcomes (3)

  • decrease in ENL score

  • absence of new nerve function impairment

  • incidence of adverse effects

Interventions

montelukast in treatment of ENL reactionDRUG

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Bangladesh Leprosy Mission Hospital

Nilphamari, Nilphamari, 5300, Bangladesh

Location

MeSH Terms

Conditions

Leprosy

Interventions

montelukast

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Abdul H Salim, MBBS

    Damien Foundation Bangladesh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdul H Salim, MBBS

CONTACT

880173011135dfsalim@citechco.net

Cynthia R Butlin, MBBCh MRCGP

CONTACT

0551 61372drruth@rediffmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2006

First Posted

December 4, 2006

Study Start

December 1, 2006

Study Completion

June 1, 2009

Last Updated

December 4, 2006

Record last verified: 2006-11

Locations

BA(1)