Ciclosporin in the Management of New Erythema Nodosum Lep... | NCT00919542

Studies
Ciclosporin in the Management of New Erythema Nodosum Leprosum

NCT00919542

Sponsor

London School of Hygiene and Tropical Medicine

Status

Completed

Last Update Posted

Mar 24, 2015Estimated

Enrollment

12Actual

Phase

Phase 2

Conditions

Leprosy

Interventions

Ciclosporin
prednisolone

Countries

Ethiopia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jun 11, 2009

First Submission Date that Met QC Criteria

Jun 11, 2009

First Posted Date

Jun 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2015

Last Update Posted Date

Mar 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Saba Lambert, Clinical Research Fellow, London School of Hygiene and Tropical MedicinePrincipal Investigator

Lead Sponsor

London School of Hygiene and Tropical MedicineOTHER

Collaborators

Name	Class
Homes and Hospitals of St Giles	OTHER
Alert Hospital, Ethiopia	OTHER
Armauer Hansen Research Institute, Ethiopia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
prednisolone	Active Comparator	standard course of prednisolone given in a reducing regimen over 16 weeks	Drug: prednisolone
Ciclosporin	Experimental	ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)	Drug: Ciclosporin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ciclosporin	Drug	Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)	Ciclosporin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of ENL recurrence episodes per patient		up to 32 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean time to ENL recurrence after initial control		up to 32 weeks
Amount of additional prednisolone required by patients		up to 32 weeks
Frequency of adverse events for patients in each treatment arm

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Diana NJ Lockwood, MBchB	London SHTM	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alert Hospital		Addis Ababa			Ethiopia

Condition Browse Module

MeSH Terms

ID	Term
D007918	Leprosy

Ancestor Terms

ID	Term
D009165	Mycobacterium Infections, Nontuberculous
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016572	Cyclosporine
D011239	Prednisolone
D000305	Adrenal Cortex Hormones

Ancestor Terms

ID	Term
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided