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Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

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: prednisolone (Drug); ciclosporin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: London School of Hygiene and Tropical Medicine

Official(s) and/or principal investigator(s):
Diana NJ Lockwood, MBChB, Principal Investigator, Affiliation: London School of Hygiene and Tropical Medicine

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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: number of ENL recurrence episodes per patient

Secondary outcome:

Mean time to ENL recurrence after initial control

Severity of ENL at recurrence

Amount of additional prednisolone required by patients

Frequency of adverse events for patients in each treatment arm

Difference in score in Quality of Life assessment between start and end for patients in each treatment arm

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Alert Hospital, Addis Abeba, Ethiopia
Additional Information

Starting date: August 2010
Last updated: March 25, 2015

Page last updated: August 23, 2015

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