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

This study has been completed.

Study NCT00444106 Information provided by Novartis

First Received on March 6, 2007. Last Updated on April 1, 2011 History of Changes

Results First Received: December 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Malaria Falciparum
Interventions:	Drug: Artesunate-mefloquine Drug: Atovaquone-proguanil Drug: Artemether-lumefantrine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Artemether-lumefantrine (Coartem)	Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
Atovaquone-proguanil (Malarone)	Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
Artesunate-mefloquine	Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.

Participant Flow: Overall Study

	Artemether-lumefantrine (Coartem)	Atovaquone-proguanil (Malarone)	Artesunate-mefloquine
STARTED	159	53	53
Completed Treatment Period	159	53	53
COMPLETED	157	52	52
NOT COMPLETED	2	1	1
Lost to Follow-up	2	1	0
Abnormal Test Procedure Results	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Artemether-lumefantrine (Coartem)	Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
Atovaquone-proguanil (Malarone)	Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
Artesunate-mefloquine	Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.

Baseline Measures

	Artemether-lumefantrine (Coartem)	Atovaquone-proguanil (Malarone)	Artesunate-mefloquine	Total
Number of Participants [units: participants]	159	53	53	265
Age [units: participants]
<=18 years	51	21	18	90
Between 18 and 65 years	108	32	35	175
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	25.6 ± 11.6	25.1 ± 11.16	25.2 ± 11.26	25.4 ± 11.4
Gender [units: participants]
Female	63	19	22	104
Male	96	34	31	161
Body Weight [units: kg] Mean ± Standard Deviation	62.8 ± 14.39	60.3 ± 14.54	65.2 ± 15.37	62.8 ± 14.64

Outcome Measures

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1. Primary:

Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test) [ Time Frame: 7 days ]

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2. Secondary:

Auditory Changes Following 3 Days of Treatment at Days 3, 7, 28, and 42 Days as Assessed by Pure Tone Thresholds Assessments (a Type of Hearing Test) [ Time Frame: Baseline (Day 1), 3, 7, 28 and Day 42 ]

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3. Secondary:

Relationship Between Changes in Auditory Function and Treatment Groups [ Time Frame: From Baseline to Day 7 ]

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4. Secondary:

Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42 [ Time Frame: Days 14, 28 and 42 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00444106 History of Changes
Other Study ID Numbers:	CCOA566A2417
Study First Received:	March 6, 2007
Results First Received:	December 8, 2010
Last Updated:	April 1, 2011
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos