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An Evaluation of Weekly Tafenoquine

Information source: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Falciparum Parasitaemia

Intervention: Tafenoquine (Drug); Mefloquine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: U.S. Army Medical Research and Materiel Command

Official(s) and/or principal investigator(s):
Jose Stoute, MD, Principal Investigator, Affiliation: Penn State Hershey Infectious Diseases


This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of P. falciparum in Nyanza Province, western Kenya.

Clinical Details

Official title: A Randomized, Double Blind, Placebo Controlled Evaluation of Weekly Tafenoquine (WR 238605/SB252263) Compared to Mefloquine for Chemosuppression of Plasmodium Falciparum in Western Kenya

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Prophylactic outcome defined by the subject having no positive smears.

Secondary outcome:

Number of subjects with two consecutive positive smears.

Number of subjects with a single positive smear during the prophylactic treatment phase plus follow-up.

Number of subjects with two consecutive positive smears

Time to a single positive smear.

Time to two consecutive positive smears


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- Healthy male or female volunteers who provided informed consent (a healthy volunteer

was defined as one who was free of ailments that might cause difficulty in evaluating drug efficacy or adverse experiences).

- Subjects aged 18-55 years.

- Subjects planning to reside in the study area for the entire study duration of

approximately 70 weeks Exclusion Criteria:

- Subjects with positive parasitaemia following halofantrine treatment for radical


- Subjects with any medical condition which, in the opinion of the investigator, made

the subject unsuitable to enter the study.

- Subjects with personal or family history of seizures.

- Female subjects with a positive serum beta-HCG5 (tested during screening and within

48 hours of first drug administration and approximately monthly thereafter).

- Women who were pregnant or lactating or who in the opinion of the investigator were

at risk of becoming pregnant.

- Subjects with clinically significant abnormalities (to include but not limited to

abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and haematology values. Subjects who had demonstrated hypersensitivity to any of the study drugs especially to any other 8-aminoquinolines.

- Subjects unwilling to report for drug administration or blood drawing during the 70

week duration of the study.

- Subjects with G6PD deficiency.

- Subjects with laboratory guideline values for exclusion: haemoglobin <10 gm/dL,

platelets <80,000/mm3, WBC <3000ul3, creatinine or ALT more than twice the upper limit of normal for age.

- Subjects with an abnormal ECG, particularly an extended QTc interval > 0. 42 seconds.

- Subjects taking any other anti-malarial product, or who had taken an antimalarial

drug other than halofantrine within the previous two weeks.

- Subjects who had received an investigational drug (a new chemical entity not

registered for use) within 30 days or 5 half-lives whichever was the longer.

- Subjects with a history of psychiatric disorder.

Locations and Contacts

Additional Information

Starting date: May 2000
Last updated: July 1, 2015

Page last updated: August 23, 2015

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