Ciclosporin in the Management of New Erythema Nodosum Leprosum

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00919542
First received: June 11, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 11, 2009
June 11, 2009
July 2009
Not Provided
time to relapse of ENL after initial control of symptoms [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • time, in hours, to control initial episode of ENL relapse from time of starting anti-reactional medication [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • time, in days, to ENL relapse from date of stopping anti-reactional medication [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ciclosporin in the Management of New Erythema Nodosum Leprosum
A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.

Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum

Objective: A pilot (double blind controlled) study randomizing patientsto treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Leprosy
  • Drug: Ciclosporin
    Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
  • Drug: prednisolone
    prednisolone 40mg daily then reducing regimen over 16 weeks
  • Active Comparator: prednisolone
    standard course of prednisolone given in a reducing regimen over 16 weeks
    Intervention: Drug: prednisolone
  • Experimental: Ciclosporin
    ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
    Intervention: Drug: Ciclosporin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
12
Not Provided
Not Provided

Inclusion Criteria:

  • Individuals with clinical evidence of new ENL
  • Aged 18-65
  • Weigh more than 30Kg

Exclusion Criteria:

  • Unwillingness to give informed consent
  • Patients with severe active infections such as tuberculosis
  • Pregnant or breastfeeding women (see Appendix II)
  • Those with renal failure, abnormal renal function, hypertensive
  • Patients taking thalidomide currently or within the last 3 months
  • Patients not willing to return for follow-up
  • Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
  • HIV positive patients
Female
18 Years to 65 Years
No
Contact: Saba M Lambert, MBChB +447921266473 saba.lambert@lshtm.ac.uk
Contact: Diana NJ Lockwood, MBChB +44 20 7927 2457 diana.lockwood@lshtm.ac.uk
Ethiopia
 
NCT00919542
ITCRBY24-ENLA
Yes
Professor Diana Lockwood, London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
  • Homes and Hospitals of St Giles
  • Alert Hospital, Ethiopia
  • Armauer Hansen Research Institute, Ethiopia
Not Provided
London School of Hygiene and Tropical Medicine
June 2009

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