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| Sponsored by: |
Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00444106 |
Purpose
To evaluate the potential effects of artemether- lumefantrine on the auditory function
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria Falciparum |
Drug: artesunate-mefloquine Drug: atovaquone-proguanil Drug: Artemether-lumefantrine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, Randomized, Single-Center, Parallel Group Study of the Effects of Artemether-Lumefantrine (Coartem®) Atovaquone-Proguanil (Malarone®) and Artesunate-Mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older |
| Enrollment: | 265 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | November 2008 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Artemether-lumefantrine
Artemether-lumefantrine
|
| 2: Active Comparator | Drug: atovaquone-proguanil |
| 3: Active Comparator | Drug: artesunate-mefloquine |
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria 12 years of age or older P. falciparum parasitemia between 1,000 and 100,000 parasites/μl History of fever or presence of fever (temperature ≥ 37.5°C)
Exclusion Criteria Signs/symptoms of severe/complicated malaria Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months History of any drug-related hearing impairment. Abnormal hearing function at study entry Exposure to sustained loud noises, by self-report, within the past 24 hours. Present ear problems Pregnant or lactating (urine test for β-HCG) to be performed on any woman of child bearing age) Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations More Information
| Responsible Party: | novartis ( novartis ) |
| Study ID Numbers: | CCOA566A2417 |
| Study First Received: | March 6, 2007 |
| Last Updated: | March 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00444106 History of Changes |
| Health Authority: | Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos |
|
Malaria hearing coartemether auditory Plasmodium falciparum marsh fever Plasmodium infections |
remittent fever paludism artemether artemisinins benflumetol lumefantrine |
|
Antimetabolites Artesunate Benflumetol Protozoan Infections Artemether-lumefantrine combination Malarone Artemisinine Anthelmintics Malaria Malaria, Falciparum |
Artemether Fever Antimalarials Artemisinins Atovaquone Antifungal Agents Chloroguanide Parasitic Diseases Mefloquine |
|
Antimetabolites Benflumetol Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Malaria Artemether Antimalarials Antiparasitic Agents Therapeutic Uses Antifungal Agents Chloroguanide Parasitic Diseases Amebicides |
Mefloquine Coccidiostats Artesunate Protozoan Infections Malarone Coccidiosis Antiplatyhelmintic Agents Enzyme Inhibitors Anthelmintics Schistosomicides Pharmacologic Actions Malaria, Falciparum Atovaquone |
