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| Tracking Information | |||||
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| First Received Date ICMJE | March 6, 2007 | ||||
| Last Updated Date | March 9, 2010 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test). | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00444106 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | To evaluate the potential effects of artemether- lumefantrine on the auditory function |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 265 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Colombia | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00444106 | ||||
| Responsible Party | novartis, novartis | ||||
| Study ID Numbers ICMJE | CCOA566A2417 | ||||
| Study Sponsor ICMJE | Novartis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||
| Verification Date | March 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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