Montelukast in ENL Reaction
Primary Purpose
Erythema Nodosum Leprosum, Leprosy
Status
Unknown status
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
montelukast in treatment of ENL reaction
Sponsored by
About this trial
This is an interventional treatment trial for Erythema Nodosum Leprosum focused on measuring reaction, ENL, leprosy
Eligibility Criteria
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
Sites / Locations
- Danish Bangladesh Leprosy Mission Hospital
Outcomes
Primary Outcome Measures
decrease in ENL score
absence of new nerve function impairment
incidence of adverse effects
Secondary Outcome Measures
Full Information
NCT ID
NCT00406861
First Posted
December 1, 2006
Last Updated
December 1, 2006
Sponsor
The Leprosy Mission Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT00406861
Brief Title
Montelukast in ENL Reaction
Official Title
Montelukast as an Alternative or Supplementary Treatment in ENL Reaction in Leprosy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2009 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Leprosy Mission Bangladesh
4. Oversight
5. Study Description
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
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 complication of Multibacillary (MB) leprosy liable to result in permanent disability if not well treated. The drug of choice is either prednisolone ( which often causes adverse effects especially with prolonged use) or thalidomide which is not available in Bangladesh.Clofazimine in high doses is recommended as an alternative but supplies are difficult to obtain. Hence the need for an alternative drug which could be used as a steroid sparing agent or an alternative to steroids in ENL reaction. Montelukast is a leukotriene inhibitor already available on the open market in this country as an immunomodulator, and a small clinical trial with zafirlukast ( very similar drug) suggested that drugs in this group may be effective for ENL.
This is a phase two trial to assess the safety and efficacy of montelukast as an alternative or supplementarry treatment for ENL reaction.
Eligible patients presenting to one of the participating hospitals with ENL reaction will be randomly allocated to one of three groups to receive prednisolone only or prednisolone plus montelukast or montelukast alone. Any patients who have major contra-indications to steroids will be put into a separate observational group and receive montelukast only.
Drug regimens are prednisolone starting at 40 mg od nd tapered over 12 weeks. Montelukast 10mg od for 16 weeks.
The patients will be monitored weekly for 8 weeks then monthly for 4 months.
At least 20 patients will be enrolled in each group.
The patients will be closely observed for adverse effects, and any who deteriorate will receieve additional steroid according to the protocol. Any who develop new nerve function impairment will be removed from the trial and given a full course of prednisolone.
Analysis will be done on an intention to treat basis and will look for any statistically significant difference in ENL score at 2 weeks, 12 weeks and 24 weeks, or a difference in the number of patients who develop new nerve function impairment, as well as the incidence and severity of any adverse effects in each group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema Nodosum Leprosum, Leprosy
Keywords
reaction, ENL, leprosy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
montelukast in treatment of ENL reaction
Primary Outcome Measure Information:
Title
decrease in ENL score
Title
absence of new nerve function impairment
Title
incidence of adverse effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdul H Salim, MBBS
Phone
880173011135
Email
dfsalim@citechco.net
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia R Butlin, MBBCh MRCGP
Phone
0551 61372
Ext
235
Email
drruth@rediffmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul H Salim, MBBS
Organizational Affiliation
Damien Foundation Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Bangladesh Leprosy Mission Hospital
City
Nilphamari,
State/Province
Nilphamari
ZIP/Postal Code
5300
Country
Bangladesh
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia R Butlin, MBBCh MRCGP
12. IPD Sharing Statement
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Montelukast in ENL Reaction
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