Ciclosporin in the Management of New Erythema Nodosum Leprosum
NCT ID: NCT00919542
Last Updated: 2015-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2010-07-31
2013-07-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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prednisolone
standard course of prednisolone given in a reducing regimen over 16 weeks
prednisolone
prednisolone 40mg daily then reducing regimen over 16 weeks
Ciclosporin
ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
Ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
Interventions
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Ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
prednisolone
prednisolone 40mg daily then reducing regimen over 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18-65
* Weigh more than 30Kg
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Homes and Hospitals of St Giles
OTHER
Alert Hospital, Ethiopia
OTHER
Armauer Hansen Research Institute, Ethiopia
OTHER
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Saba Lambert
Clinical Research Fellow
Principal Investigators
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Diana NJ Lockwood, MBchB
Role: STUDY_DIRECTOR
London SHTM
Locations
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Alert Hospital
Addis Ababa, , Ethiopia
Countries
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Other Identifiers
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ITCRBY24-ENLA
Identifier Type: -
Identifier Source: org_study_id
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