Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 6:35 AM
Study NCT ID:
NCT00444106
Status:
COMPLETED
Last Update Posted:
2011-04-05
First Post:
2007-03-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D016778', 'term': 'Malaria, Falciparum'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015767', 'term': 'Mefloquine'}, {'id': 'C109496', 'term': 'atovaquone, proguanil drug combination'}, {'id': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}], 'ancestors': [{'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077549', 'term': 'Artemether'}, {'id': 'D037621', 'term': 'Artemisinins'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000078102', 'term': 'Lumefantrine'}, {'id': 'D005449', 'term': 'Fluorenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety Set- All patients who received at least one dose of study drug and had at least one post baseline safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Artemether-lumefantrine', 'description': 'Artemether-lumefantrine', 'otherNumAtRisk': 159, 'otherNumAffected': 23, 'seriousNumAtRisk': 159, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Atovaquone-proguanil', 'description': 'Atovaquone-proguanil', 'otherNumAtRisk': 53, 'otherNumAffected': 17, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Artesunate-Mefloquine', 'description': 'Artesunate-Mefloquine', 'otherNumAtRisk': 53, 'otherNumAffected': 30, 'seriousNumAtRisk': 53, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Artemether-lumefantrine (Coartem)', 'description': 'Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '6.6'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'One-sided null hypothesis that the incidence rate of ABR Wave III latency changes is greater than or equal to 15%.\n\nIncrease in ABR Wave III latency between baseline and Day 7 of greater than 0.3 ms.', 'statisticalMethod': 'One-sided exact test for a single propn.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One-sided exact test for a single proportion.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An "auditory nerve abnormality" is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety per protocol set defined as all the randomized patients who took at least 80% of the entire recommended dose and had a valid baseline and Day 7 ABR Wave III latency evaluation and did not use any meds having an ototoxic effect.'}, {'type': 'SECONDARY', 'title': '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)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Artemether-lumefantrine', 'description': 'Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.'}, {'id': 'OG001', 'title': 'Atovaquone-proguanil (Malarone)', 'description': 'Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.'}, {'id': 'OG002', 'title': 'Artesunate-mefloquine', 'description': '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.'}], 'classes': [{'title': 'Baseline Right Ear', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '13.0'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '13.6'}, {'value': '12.7', 'groupId': 'OG002', 'lowerLimit': '11.2', 'upperLimit': '14.2'}]}]}, {'title': 'Change from baseline to Day 3 Right Ear', 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '-1.9'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-3.6', 'upperLimit': '-1.2'}, {'value': '-1.9', 'groupId': 'OG002', 'lowerLimit': '-3.0', 'upperLimit': '-0.7'}]}]}, {'title': 'Change from baseline to Day 7 Right Ear', 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '-1.5'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '-1.1'}, {'value': '-2.6', 'groupId': 'OG002', 'lowerLimit': '-3.9', 'upperLimit': '-1.3'}]}]}, {'title': 'Change from baseline to Day 28 Right Ear', 'categories': [{'measurements': [{'value': '-2.7', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-1.9'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-4.2', 'upperLimit': '-1.0'}, {'value': '-3.6', 'groupId': 'OG002', 'lowerLimit': '-4.8', 'upperLimit': '-2.3'}]}]}, {'title': 'Change from baseline to Day 42 Right Ear', 'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '-2.2'}, {'value': '-3.3', 'groupId': 'OG001', 'lowerLimit': '-4.9', 'upperLimit': '-1.7'}, {'value': '-3.1', 'groupId': 'OG002', 'lowerLimit': '-4.2', 'upperLimit': '-1.9'}]}]}, {'title': 'Baseline Left Ear', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '12.3'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '12.7'}, {'value': '12.5', 'groupId': 'OG002', 'lowerLimit': '10.8', 'upperLimit': '14.3'}]}]}, {'title': 'Change from baseline to Day 3 Left Ear', 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '-0.5'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '-0.3'}, {'value': '-1.2', 'groupId': 'OG002', 'lowerLimit': '-2.2', 'upperLimit': '-0.1'}]}]}, {'title': 'Change from baseline to Day 7 Left Ear', 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '-0.9'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '0.2'}, {'value': '-1.4', 'groupId': 'OG002', 'lowerLimit': '-2.8', 'upperLimit': '-0.1'}]}]}, {'title': 'Change from baseline to Day 28 Left Ear', 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '-1.1'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '-0.5'}, {'value': '-2.5', 'groupId': 'OG002', 'lowerLimit': '-4.3', 'upperLimit': '-0.7'}]}]}, {'title': 'Change from baseline to Day 42 Left Ear', 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '-0.4'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '-0.6'}, {'value': '-3.0', 'groupId': 'OG002', 'lowerLimit': '-4.7', 'upperLimit': '-1.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), 3, 7, 28 and Day 42', 'description': 'Audiometric measurements such as pure-tone threshold (air conduction tested at 250 to 8000 HZ) day 3, 7, 28 and 42 following initiation of treatment, including changes from baseline. Pure-tone average (PTA) calculated for each ear by averaging the pure-tone threshold values at 500, 1000, 2000 and 3000 HZ.', 'unitOfMeasure': 'dB', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety per protocol patients who had a valid ABR at baseline and on the specified day were included.'}, {'type': 'SECONDARY', 'title': 'Relationship Between Changes in Auditory Function and Treatment Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Artemether-lumefantrine (Coartem)', 'description': 'Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.'}, {'id': 'OG001', 'title': 'Atovaquone-proguanil (Malarone)', 'description': 'Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.'}, {'id': 'OG002', 'title': 'Artesunate-mefloquine', 'description': '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.'}], 'classes': [{'title': 'Baseline Right Ear', 'categories': [{'measurements': [{'value': '3.86', 'groupId': 'OG000', 'lowerLimit': '3.83', 'upperLimit': '3.90'}, {'value': '3.89', 'groupId': 'OG001', 'lowerLimit': '3.84', 'upperLimit': '3.94'}, {'value': '3.86', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '3.93'}]}]}, {'title': 'Change from baseline to Day 7 Right Ear', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.01', 'upperLimit': '0.03'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.02'}, {'value': '-0.04', 'groupId': 'OG002', 'lowerLimit': '-0.08', 'upperLimit': '0.01'}]}]}, {'title': 'Baseline Left Ear', 'categories': [{'measurements': [{'value': '3.85', 'groupId': 'OG000', 'lowerLimit': '3.82', 'upperLimit': '3.88'}, {'value': '3.88', 'groupId': 'OG001', 'lowerLimit': '3.84', 'upperLimit': '3.93'}, {'value': '3.82', 'groupId': 'OG002', 'lowerLimit': '3.77', 'upperLimit': '3.88'}]}]}, {'title': 'Change from baseline to Day 7 Left Ear', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.01', 'upperLimit': '0.03'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.02'}, {'value': '-0.03', 'groupId': 'OG002', 'lowerLimit': '-0.07', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Day 7', 'description': 'ABR Wave III latency (ms) changes from baseline to Day 7 in the three drug exposure groups.', 'unitOfMeasure': 'ms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Artemether-lumefantrine (Coartem)', 'description': 'Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.'}, {'id': 'OG001', 'title': 'Atovaquone-proguanil (Malarone)', 'description': 'Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.'}, {'id': 'OG002', 'title': 'Artesunate-mefloquine', 'description': '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.'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '100.0'}, {'value': '98.1', 'groupId': 'OG002', 'lowerLimit': '89.9', 'upperLimit': '100.0'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '99.8'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '89.9', 'upperLimit': '100.0'}, {'value': '98.1', 'groupId': 'OG002', 'lowerLimit': '89.9', 'upperLimit': '100.0'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '99.3'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '98.1', 'groupId': 'OG002', 'lowerLimit': '89.9', 'upperLimit': '100.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 14, 28 and 42', 'description': 'Percentage of patients with clearance of asexual parasitemia (observed by optical microscopy) within 7 days of initiation of trial treatment without recrudescence within 14, 28 and 42 days respectively after initiation of treatment. Patients with recurrent parasitemia and paired PCR results were classified as either a new infection (different paired genotypes) or a recrudescence (matching paired genotypes). Patients without paired PCR results or ambiguous results were classified as treatment failures.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as all randomized patients with confirmed malaria at baseline, who had at least one dose of study drug and had at least one relevant post-baseline efficacy assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Artemether-lumefantrine (Coartem)', 'description': 'Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.'}, {'id': 'FG001', 'title': 'Atovaquone-proguanil (Malarone)', 'description': 'Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.'}, {'id': 'FG002', 'title': 'Artesunate-mefloquine', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'Completed Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Abnormal Test Procedure Results', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Artemether-lumefantrine (Coartem)', 'description': 'Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.'}, {'id': 'BG001', 'title': 'Atovaquone-proguanil (Malarone)', 'description': 'Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.'}, {'id': 'BG002', 'title': 'Artesunate-mefloquine', 'description': '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.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '25.1', 'spread': '11.16', 'groupId': 'BG001'}, {'value': '25.2', 'spread': '11.26', 'groupId': 'BG002'}, {'value': '25.4', 'spread': '11.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '14.39', 'groupId': 'BG000'}, {'value': '60.3', 'spread': '14.54', 'groupId': 'BG001'}, {'value': '65.2', 'spread': '15.37', 'groupId': 'BG002'}, {'value': '62.8', 'spread': '14.64', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 265}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-01', 'studyFirstSubmitDate': '2007-03-06', 'resultsFirstSubmitDate': '2010-12-08', 'studyFirstSubmitQcDate': '2007-03-06', 'lastUpdatePostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-22', 'studyFirstPostDateStruct': {'date': '2007-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': '7 days', 'description': 'To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An "auditory nerve abnormality" is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups.'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': 'Baseline (Day 1), 3, 7, 28 and Day 42', 'description': 'Audiometric measurements such as pure-tone threshold (air conduction tested at 250 to 8000 HZ) day 3, 7, 28 and 42 following initiation of treatment, including changes from baseline. Pure-tone average (PTA) calculated for each ear by averaging the pure-tone threshold values at 500, 1000, 2000 and 3000 HZ.'}, {'measure': 'Relationship Between Changes in Auditory Function and Treatment Groups', 'timeFrame': 'From Baseline to Day 7', 'description': 'ABR Wave III latency (ms) changes from baseline to Day 7 in the three drug exposure groups.'}, {'measure': 'Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42', 'timeFrame': 'Days 14, 28 and 42', 'description': 'Percentage of patients with clearance of asexual parasitemia (observed by optical microscopy) within 7 days of initiation of trial treatment without recrudescence within 14, 28 and 42 days respectively after initiation of treatment. Patients with recurrent parasitemia and paired PCR results were classified as either a new infection (different paired genotypes) or a recrudescence (matching paired genotypes). Patients without paired PCR results or ambiguous results were classified as treatment failures.'}]}, 'conditionsModule': {'keywords': ['Malaria', 'hearing', 'co-artemether', 'auditory', 'Plasmodium falciparum', 'marsh fever', 'Plasmodium infections', 'remittent fever', 'paludism', 'artemether', 'artemisinins', 'benflumetol', 'lumefantrine'], 'conditions': ['Malaria', 'Falciparum']}, 'descriptionModule': {'briefSummary': 'To evaluate the potential effects of artemether- lumefantrine on the auditory function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'eligibilityCriteria': 'Inclusion Criteria\n\n* 12 years of age or older\n* Accepts Healthy Volunteers\n* P. falciparum parasitemia between 1,000 and 100,000 parasites/μl\n* History of fever or presence of fever (temperature ≥ 37.5°C)\n\nExclusion Criteria\n\n* Signs/symptoms of severe/complicated malaria\n* Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months\n* History of any drug-related hearing impairment\n* Abnormal hearing function at study entry\n* Exposure to sustained loud noises, by self-report, within the past 24 hours\n* Present ear problems\n* Pregnant or lactating (urine test for β-HCG) to be performed on any woman of child bearing age)\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00444106', 'briefTitle': 'Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CCOA566A2417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Artemether-lumefantrine (Coartem)', 'description': 'Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days, dosage dependent on body weight.', 'interventionNames': ['Drug: Artemether-lumefantrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atovaquone-proguanil (Malarone)', 'description': 'Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days, dosage dependent on body weight.', 'interventionNames': ['Drug: Atovaquone-proguanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Artesunate-mefloquine', 'description': 'Artesunate-mefloquine tablets containing 50 mg artesunate (Plasmotrim) and 250 mg mefloquine (Mephaquin). Artesunate 4 mg/kg/day (for 3 days) and mefloquine 25 mg/kg/day (days 2 and 3) total dose was given once daily dependent upon body weight.', 'interventionNames': ['Drug: Artesunate-mefloquine']}], 'interventions': [{'name': 'Artesunate-mefloquine', 'type': 'DRUG', 'otherNames': ['Plasmotrim', 'Mephaquin'], 'armGroupLabels': ['Artesunate-mefloquine']}, {'name': 'Atovaquone-proguanil', 'type': 'DRUG', 'otherNames': ['Malarone'], 'armGroupLabels': ['Atovaquone-proguanil (Malarone)']}, {'name': 'Artemether-lumefantrine', 'type': 'DRUG', 'otherNames': ['Coartem'], 'armGroupLabels': ['Artemether-lumefantrine (Coartem)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tumaco', 'country': 'Colombia', 'facility': 'Novartis Investigational Site', 'geoPoint': {'lat': 1.79112, 'lon': -78.79275}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Novartis', 'oldOrganization': 'Novartis'}}}}