Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)

This study has been completed.

Sponsor:

Collaborator:

World Health Organization

Information provided by (Responsible Party):

AB Foundation

ClinicalTrials.gov Identifier:

NCT01635777

First received: July 3, 2012

Last updated: July 9, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 3, 2012
Last Updated Date	July 9, 2012
Start Date ^ICMJE	July 2007
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 9, 2012)	Cure rate [ Time Frame: 12 months after end of treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01635777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 9, 2012)	adverse events [ Time Frame: during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group ] [ Designated as safety issue: Yes ] gastrointestinal events: vomiting and diarrhea
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
Official Title ^ICMJE	Not Provided
Brief Summary	Miltefosine efficacy will be >85%
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	PKDL
Intervention ^ICMJE	Drug: Miltefosine 2.5 mg/kg/day for 12 weeks Drug: Miltefosine 2.5 mg/kg/day for 8 weeks
Study Arm (s)	Experimental: 12 weeks miltefosine 12 weeks Intervention: Drug: Miltefosine Experimental: 8 weeks miltefosine 8 weeks Intervention: Drug: Miltefosine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	37
Completion Date	December 2010
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 12 years or older nodules and papules consistent with post kala-azar dermal leishmaniasis parasitological confirmation of Leishmania infection Exclusion Criteria: platelet count <100x 109/l, leukocyte count <2.5 x 109/l , hemoglobin < 8.0 g/100 ml , liver function tests >3 times upper limit of normal range, bilirubin >2 times upper limit of normal range, serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range); any non-compensated or uncontrolled condition, lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter; treatment with any anti-leishmanial drug within the previous 12 weeks.
Gender	Both
Ages	12 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	India

Administrative Information
NCT Number ^ICMJE	NCT01635777
Other Study ID Numbers ^ICMJE	Z015
Has Data Monitoring Committee	No
Responsible Party	AB Foundation
Study Sponsor ^ICMJE	AB Foundation
Collaborators ^ICMJE	World Health Organization
Investigators ^ICMJE	Not Provided
Information Provided By	AB Foundation
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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