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Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis

NCT00255567 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1142

Last updated 2016-03-22

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Sodium Stibogluconate

Sodium Stibogluconate 20mg/kg/day for 30 days

DRUG

Paromomycin sulphate

Paromomycin sulphate

DRUG

SSG and Paromomycin sulphate

SSG and Paromomycin Sulphate 17 days

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Manica Balasegaram · Drugs for Neglected Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Ethiopia
  • Kenya
  • Sudan
  • Uganda

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 NCT00255567 on ClinicalTrials.gov