Montelukast in ENL Reaction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by The Leprosy Mission Bangladesh.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
The Leprosy Mission Bangladesh
ClinicalTrials.gov Identifier:
NCT00406861
First received: December 1, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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


Condition Intervention
Erythema Nodosum Leprosum
Leprosy
Drug: montelukast in treatment of ENL reaction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Montelukast as an Alternative or Supplementary Treatment in ENL Reaction in Leprosy

Resource links provided by NLM:


Further study details as provided by The Leprosy Mission Bangladesh:

Primary Outcome Measures:
  • decrease in ENL score
  • absence of new nerve function impairment
  • incidence of adverse effects

Estimated Enrollment: 60
Study Start Date: December 2006
Estimated Study Completion Date: June 2009
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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406861

Contacts
Contact: Abdul H Salim, MBBS 880173011135 dfsalim@citechco.net
Contact: Cynthia R Butlin, MBBCh MRCGP 0551 61372 ext 235 drruth@rediffmail.com

Locations
Bangladesh
Danish Bangladesh Leprosy Mission Hospital Not yet recruiting
Nilphamari,, Nilphamari, Bangladesh, 5300
Principal Investigator: Cynthia R Butlin, MBBCh MRCGP         
Sponsors and Collaborators
The Leprosy Mission Bangladesh
Investigators
Principal Investigator: Abdul H Salim, MBBS Damien Foundation Bangladesh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00406861     History of Changes
Other Study ID Numbers: BMRCERC2004-2007627
Study First Received: December 1, 2006
Last Updated: December 1, 2006
Health Authority: Bangladesh: Bangladesh Medical Research Council

Keywords provided by The Leprosy Mission Bangladesh:
reaction
ENL
leprosy

Additional relevant MeSH terms:
Leprosy
Erythema Nodosum
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Drug Eruptions
Dermatitis
Skin Diseases
Erythema
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014