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

NCT00629031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2008-09-12

No results posted yet for this study

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.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Paromomycin

11 mg/kg for 14 days

DRUG

Paromomycin

Paromomycin for 21 days @ 11mg/kg by intramuscular injections

Sponsors & Collaborators

  • Banaras Hindu University

    lead OTHER

Principal Investigators

  • Shyam Sundar, MD · Banaras Hindu University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-02-29
Completion
2008-08-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00629031 on ClinicalTrials.gov