Trials / Terminated
TerminatedNCT00988507
Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Parallel Group, Double-blind, Randomized Study Assessing the Efficacy, Safety and Pharmacokinetic Profiles of Ferroquine Associated With Artesunate and a Single-blind Dose Level of Ferroquine Alone in a 3-day Treatment of Uncomplicated Malaria Due to Plasmodium Falciparum in an Immune Symptomatic African Adult and Pediatric Population.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
The overall study duration is 64 days, consisting of a screening period (less or equal 1 day), of a 3-day treatment period during which the patient is hospitalized for a maximum of 60 hours, and a follow-up period of 61 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2009-10-02
- Last updated
- 2011-06-28
Locations
10 sites across 6 countries: Benin, Burkina Faso, Cameroon, Gabon, Kenya, Tanzania
Source: ClinicalTrials.gov record NCT00988507. Inclusion in this directory is not an endorsement.