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Mefloquine

Phase 3

Malaria | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: May 11, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment397

FDA Designations

No designations recorded

Clinical trial landscape

Mefloquine · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00367653Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.Malaria
COMPLETED397 Analytics
PHASE3COMPLETED
Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.
MalariaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa.
duration of trial
The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population.
duration of trial
Parasite clearance

Secondary Endpoints

A secondary objective is to assess the efficacy of azithromycin plus chloroquine.
duration of trial
Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.
duration of trial
tolerability
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -

Interventions

NameTypeDescription
Azithromycin plus ChloroquineDRUGAzithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)
MefloquineDRUGMefloquine 1250 mg PO given as a split dose (750 mg \[three 250 mg capsules\]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0
Azithromycin/ChloroquineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following: * Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites * Documented fever (38.5 C/101.3 ...

Countries:Burkina FasoGhanaKenyaMaliSenegalZambiaUganda
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Competitive Landscape -Malaria 6 trials

Frequently asked questions about Mefloquine

What is Mefloquine used for?

Mefloquine is used for the treatment of uncomplicated malaria, including falciparum malaria. It is being studied in clinical trials for this infectious disease indication. The drug is administered to adult patients, and trials have been conducted in multiple African countries where malaria is prevalent.

Who makes Mefloquine?

Mefloquine is being developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug for the treatment of uncomplicated malaria in adult patients.

What phase is Mefloquine in?

Mefloquine is in Phase 3 clinical development for the treatment of uncomplicated malaria. It has completed a Phase 3 trial with 397 participants. The drug is investigational and has not been approved for this use, as it is still undergoing clinical evaluation.

What clinical trials is Mefloquine in?

Mefloquine has been studied in two completed clinical trials. One trial, NCT00082576, was a Phase 2 study comparing azithromycin plus chloroquine versus mefloquine in 238 patients with falciparum malaria. Another trial, NCT00367653, was a Phase 3 study in 397 patients with uncomplicated malaria.

Is Mefloquine the same as Lariam?

Mefloquine is the generic name for the drug also known as Lariam. In clinical trials, it is referred to as mefloquine, and it is being evaluated for the treatment of uncomplicated malaria. The drug is a small molecule developed by Pfizer.