drugset / Trial / NCT00444106

Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function

NCT00444106 ↗

Phase 4 Completed 265 enrolled Novartis
RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the potential effects of artemether- lumefantrine on the auditory function

Timeline

Start
2007-05
Primary completion
2008-11
Completion
2008-11

Outcome

Met primary endpoint

registry NUMBER Artemether-lumefantrine (Coartem): 2.6 (0.7 to 6.6) Percentage of Participants NCT00444106 ↗

registry Artemether-lumefantrine (Coartem); p <.0001; One-sided exact test for a single propn. NCT00444106 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Artemether Small molecule 20 mg Oral
Comparator Artesunate Small molecule 4 mg/kg Oral
Comparator Artesunate Small molecule 50 mg Oral
Comparator Atovaquone Small molecule 250 mg Oral
Comparator Mefloquine Unknown 25 mg/kg Oral
Comparator Mefloquine Unknown 250 mg Oral
Comparator Proguanil Small molecule 100 mg Oral
Subject lumefantrine Small molecule 120 mg Oral