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Generated: January 22, 2018

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
MEFLOQUINE HYDROCHLORIDE

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00082576 Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in AfricaCompletedPfizerPhase 2/Phase 3 The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
NCT00127998 Antimalarial Drug Resistance in MaliCompletedMalaria Research and Training Center, Bamako, MaliN/A Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic polymorphisms that give rise to resistant P. falciparum parasites and methods in population genetics for evaluating the data can be valuable tools for monitoring drug resistance in the field. This study aims to: 1. Prospectively measure the in vivo response of P. falciparum malaria in Mali to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested. 2. Measure the frequencies of molecular markers for antimalarial drug resistance, and examine how those results relate to the efficacy of these drugs in treating clinical malaria 3. Measure drug levels at 3 days and correlate with efficacy results. 4. Examine early clinical, parasitologic, and clinical predictors of late treatment failure. 5. Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for antimalarial drugs.
NCT00127998 Antimalarial Drug Resistance in MaliCompletedCenters for Disease Control and PreventionN/A Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic polymorphisms that give rise to resistant P. falciparum parasites and methods in population genetics for evaluating the data can be valuable tools for monitoring drug resistance in the field. This study aims to: 1. Prospectively measure the in vivo response of P. falciparum malaria in Mali to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested. 2. Measure the frequencies of molecular markers for antimalarial drug resistance, and examine how those results relate to the efficacy of these drugs in treating clinical malaria 3. Measure drug levels at 3 days and correlate with efficacy results. 4. Examine early clinical, parasitologic, and clinical predictors of late treatment failure. 5. Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for antimalarial drugs.
NCT00146718 Anti-Malarial Drug Resistance in CameroonCompletedUniversity of YaoundePhase 2/Phase 3 The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ), sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their baseline characteristics for malaria. In addition, drug resistance will be determined by measurement of blood drug levels,and identification of molecular markers of resistance.
NCT00146718 Anti-Malarial Drug Resistance in CameroonCompletedLondon School of Hygiene and Tropical MedicinePhase 2/Phase 3 The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ), sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their baseline characteristics for malaria. In addition, drug resistance will be determined by measurement of blood drug levels,and identification of molecular markers of resistance.
NCT00158574 Kilimanjaro IPTi Drug Options TrialCompletedKilimanjaro Christian Medical Centre, TanzaniaPhase 2/Phase 3 Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP. This study objectives are: 1. Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine. 2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi. 3. Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi. 4. Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas. A randomised trial with four treatment regimes is proposed which will be conducted in two different transmission settings. The four treatment regimens are as follows: (1) placebo; (2) mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is the incidence of clinical malaria.
NCT00158574 Kilimanjaro IPTi Drug Options TrialCompletedNational Institute for Medical Research, TanzaniaPhase 2/Phase 3 Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP. This study objectives are: 1. Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine. 2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi. 3. Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi. 4. Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas. A randomised trial with four treatment regimes is proposed which will be conducted in two different transmission settings. The four treatment regimens are as follows: (1) placebo; (2) mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is the incidence of clinical malaria.
NCT00158574 Kilimanjaro IPTi Drug Options TrialCompletedUniversity of CopenhagenPhase 2/Phase 3 Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP. This study objectives are: 1. Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine. 2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi. 3. Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi. 4. Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas. A randomised trial with four treatment regimes is proposed which will be conducted in two different transmission settings. The four treatment regimens are as follows: (1) placebo; (2) mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is the incidence of clinical malaria.
NCT00158574 Kilimanjaro IPTi Drug Options TrialCompletedGates Malaria PartnershipPhase 2/Phase 3 Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP. This study objectives are: 1. Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine. 2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi. 3. Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi. 4. Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas. A randomised trial with four treatment regimes is proposed which will be conducted in two different transmission settings. The four treatment regimens are as follows: (1) placebo; (2) mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is the incidence of clinical malaria.
NCT00164216 Efficacy and Effectiveness of Combined Therapy for Uncomplicated Malaria Treatment in PeruCompletedNational Institute of Health, PeruPhase 4 This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves. Clinical and parasitologic response will be monitored for a follow-up period of 28 days. The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P. falciparum malaria treatment.
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Conditions

Condition Name

Condition Name for mefloquine hydrochloride
Intervention Trials
Malaria 28
HIV Infections 5
Falciparum Malaria 3
Malaria, Falciparum 3
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Condition MeSH

Condition MeSH for mefloquine hydrochloride
Intervention Trials
Malaria 49
Malaria, Falciparum 17
HIV Infections 5
Malaria, Vivax 3
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Trial Locations

Trials by Country

Trials by Country for mefloquine hydrochloride
Location Trials
Thailand 12
Myanmar 8
Brazil 7
Cambodia 6
Kenya 6
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Trials by US State

Trials by US State for mefloquine hydrochloride
Location Trials
Maryland 1
Illinois 1
Texas 1
New York 1
Missouri 1
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for mefloquine hydrochloride
Clinical Trial Phase Trials
Phase 4 13
Phase 3 18
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for mefloquine hydrochloride
Clinical Trial Phase Trials
Completed 41
Terminated 8
Unknown status 6
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for mefloquine hydrochloride
Sponsor Trials
University of Oxford 10
Centers for Disease Control and Prevention 7
Medicines for Malaria Venture 5
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Sponsor Type

Sponsor Type for mefloquine hydrochloride
Sponsor Trials
Other 132
U.S. Fed 14
Industry 13
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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
AstraZeneca
Farmers Insurance
McKinsey
Harvard Business School
Citi
Healthtrust
Merck
Daiichi Sankyo
US Army

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