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Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00919776
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : March 26, 2015
Sponsor:
Collaborators:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE June 11, 2009
First Posted Date  ICMJE June 12, 2009
Last Update Posted Date March 26, 2015
Study Start Date  ICMJE August 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
number of ENL recurrence episodes per patient [ Time Frame: up to 32 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
  • Mean time to ENL recurrence after initial control [ Time Frame: up to 32 weeks ]
  • Severity of ENL at recurrence [ Time Frame: up to 32 weeks ]
  • Amount of additional prednisolone required by patients [ Time Frame: up to 32 weeks ]
  • Frequency of adverse events for patients in each treatment arm [ Time Frame: up to 32 weeks ]
  • Difference in score in Quality of Life assessment between start and end for patients in each treatment arm [ Time Frame: up to 32 weeks ]
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 Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Official Title  ICMJE A Pilot Double Blind Controlled Study Randomizing Patients Whose ENL is Not Controlled With Standard Prednisolone, and Comparing a Group Treated With Ciclosporin to a Group Treated With Additional Steroid Only.
Brief Summary

Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients whose ENL is not controlled with standard Prednisolone.

Objective: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.

Detailed Description A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Leprosy
Intervention  ICMJE
  • Drug: prednisolone
    prednisolone 40mg daily then reducing regimen over 16 weeks
    Other Name: corticosteroids
  • Drug: ciclosporin
    Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
    Other Names:
    • Cyclosporine
    • Cyclosporin A
Study Arms  ICMJE
  • Experimental: ciclosporin
    ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
    Intervention: Drug: ciclosporin
  • Active Comparator: Prednisolone
    standard course of prednisolone given in a reducing regimen over 16 weeks
    Intervention: Drug: prednisolone
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2015)
20
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)
12
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals with clinical evidence of recurrent or chronic 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 Ethiopia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00919776
Other Study ID Numbers  ICMJE ITCCRBY24-ENLB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Homes and Hospitals of St Giles
  • Alert Hospital, Ethiopia
  • Armauer Hansen Research Institute, Ethiopia
Investigators  ICMJE
Principal Investigator: Diana NJ Lockwood, MBChB London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date March 2015

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