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Ciclosporin in the Management of New Type 1 Reactions in Leprosy

NCT00919815 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2015-03-24

No results posted yet for this study

Summary

Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy

Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.

Conditions

  • Leprosy

Interventions

DRUG

Ciclosporin

Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)

DRUG

Prednisolone

prednisolone 40mg daily then reducing regimen over 24 weeks

Sponsors & Collaborators

  • Homes and Hospitals of St Giles

    collaborator OTHER

  • Alert Hospital, Ethiopia

    collaborator OTHER

  • Armauer Hansen Research Institute, Ethiopia

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Diana Lockwood, MBChB · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-12-31
Completion
2013-07-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00919815 on ClinicalTrials.gov