Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function

Phase 4

Terminated

• Conditions: Malaria; Falciparum

• Registration Number: NCT00386750
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.

To evaluate the effects of artemether/ lumefantrine on the auditory function.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-11
• Study First Posted: 2006-10-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-25
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).

Secondary Outcome Measures

Name	Time	Method
Relationship between changes in auditory function and drug exposure.
Rate of auditory changes following 3 days of treatment with artemether-lumefantrine at Days 7, 28, and 42 days assessed by pure tone thresholds assessments (a type of hearing test)
Changes in auditory function with a non-ACT (artemisinin combined therapy) antimalarial (Malarone, atovaquone-proguanil) and another ACT combination (artesunate-mefloquine) assessed by pure tone thresholds (a type of hearing test)