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Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

NCT00988507 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2011-06-28

No results posted yet for this study

Summary

Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated with artesunate - for a 3-day treatment.

Secondary objectives:

* To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment.
* To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine associated with artesunate and one dose level of ferroquine alone.
* To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse sampling schedules.

Conditions

  • Plasmodium Falciparum Infection

Interventions

DRUG

Ferroquine (SSR97193)

Pharmaceutical form: capsule Route of administration: oral

DRUG

Placebo

Pharmaceutical form: capsule Route of administration: oral

DRUG

artesunate

Pharmaceutical form: tablets Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Benin
  • Burkina Faso
  • Cameroon
  • Gabon
  • Kenya
  • Tanzania

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00988507 on ClinicalTrials.gov