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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00310505 |
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Date of registration:
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03/04/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Amphotericin B Treatment in Visceral Leishmaniasis
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Scientific title:
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Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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1500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00310505 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Shyam Sundar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Parasitologically proved kala-azar
Exclusion Criteria:
- HIV positive serology
Age minimum:
2 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Visceral Leishmaniasis
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Intervention(s)
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Drug: Amphotericin B deoxycholate given as daily administration
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Primary Outcome(s)
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Final cure rate at six months after the end of treatment
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Secondary ID(s)
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SS01MZP03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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