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Ciclosporin in the Management of New 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: NCT00919542
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : March 24, 2015
Sponsor:
Collaborators:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
Saba Lambert, 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 24, 2015
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2015)
Number of ENL recurrence episodes per patient [ Time Frame: up to 32 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
time to relapse of ENL after initial control of symptoms [ Time Frame: up to 2 years ]
Change History Complete list of historical versions of study NCT00919542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2015)
  • Mean time to ENL recurrence after initial control [ 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
 (submitted: June 11, 2009)
  • time, in hours, to control initial episode of ENL relapse from time of starting anti-reactional medication [ Time Frame: 48 hours ]
  • time, in days, to ENL relapse from date of stopping anti-reactional medication [ Time Frame: up to 2 years ]
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 New Erythema Nodosum Leprosum
Official Title  ICMJE A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.
Brief Summary

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

Objective: A pilot (double blind controlled) study randomizing patients to 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).

Detailed Description A pilot (double blind controlled) study randomizing patients to 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).
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: Ciclosporin
    Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
    Other Names:
    • cyclosporin
    • Cyclosporin A
  • Drug: prednisolone
    prednisolone 40mg daily then reducing regimen over 16 weeks
    Other Name: corticosteroids
Study Arms  ICMJE
  • 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
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: June 11, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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 NCT00919542
Other Study ID Numbers  ICMJE ITCRBY24-ENLA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Saba Lambert, 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
Study Director: Diana NJ Lockwood, MBchB London SHTM
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