drugset / Trial / NCT00629031

An Open Lable Randomised Study to Assess the Safety and Efficacy of Short Course Paromomycin in Visceral Leishmaniasis

NCT00629031

Phase 3 Completed 329 enrolled Banaras Hindu University
RandomizedParallel-groupOpen-labelTreatment

Summary

It is a randomized, double-blind, multi-center, two-arm study intended to assess the safety and efficacy of three different doses/dose regimens of paromomycin administered intramuscularly as follows: 11 mg/kg/day for 14 days and 11 mg/kg/day for 21 days for the treatment of visceral leishmaniasis (VL) in India.

Timeline

Start
2008-02
Primary completion
2008-02
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Paromomycin Small molecule 11 mg/kg Intramuscular