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Montelukast in ENL Reaction

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ClinicalTrials.gov Identifier: NCT00406861
Recruitment Status : Unknown
Verified November 2006 by The Leprosy Mission Bangladesh.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2006
Last Update Posted : December 4, 2006
Sponsor:
Information provided by:
The Leprosy Mission Bangladesh

Tracking Information
First Submitted Date  ICMJE December 1, 2006
First Posted Date  ICMJE December 4, 2006
Last Update Posted Date December 4, 2006
Study Start Date  ICMJE December 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2006)
  • decrease in ENL score
  • absence of new nerve function impairment
  • incidence of adverse effects
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Montelukast in ENL Reaction
Official Title  ICMJE Montelukast as an Alternative or Supplementary Treatment in ENL Reaction in Leprosy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Erythema Nodosum Leprosum
  • Leprosy
Intervention  ICMJE Drug: montelukast in treatment of ENL reaction
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: December 1, 2006)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00406861
Other Study ID Numbers  ICMJE BMRCERC2004-2007627
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE The Leprosy Mission Bangladesh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abdul H Salim, MBBS Damien Foundation Bangladesh
PRS Account The Leprosy Mission Bangladesh
Verification Date November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP