Ciclosporin in the Management of New Type 1 Reactions in Leprosy
Information source: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leprosy
Intervention: Ciclosporin (Drug); Prednisolone (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: London School of Hygiene and Tropical Medicine Official(s) and/or principal investigator(s): Diana Lockwood, MBChB, Principal Investigator, Affiliation: London School of Hygiene and Tropical Medicine
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.
Clinical Details
Official title: A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: improvement in nerve function and Clinical Severity Score
Secondary outcome: Incidence of adverse eventsNumber of T1R recurrence episodes per patient in each treatment arm Severity of T1R recurrence for patients in each treatment arm extra prednisolone needed to control reaction 6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm Mean time to recurrence of T1R for patients in each treatment arm
Detailed description:
We tested our hypothesis that ciclosporin would be as effective as prednisolone in the
treatment of patients with leprosy reactions and nerve function impairment and that patients
treated with ciclosporin would have fewer side effects than patients treated with
prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the
treatment of acute leprosy T1R was conducted.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Individuals with clinical evidence of T1R with new nerve function impairment (NFI).
- 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
Locations and Contacts
Alert Hospital, Addis Abeba, Ethiopia
Additional Information
Starting date: August 2010
Last updated: March 21, 2015
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