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An Evaluation of Weekly Tafenoquine

NCT02488980 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2017-05-30

Study results available
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Summary

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.

Conditions

  • Falciparum Parasitaemia

Interventions

DRUG

Tafenoquine

Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.

DRUG

Mefloquine

Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.

DRUG

Placebo

Placebo for three days followed by placebo once a week for 24 weeks

Sponsors & Collaborators

  • SmithKline Beecham

    collaborator INDUSTRY

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Jose Stoute, MD · Penn State Hershey Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-05-31
Primary Completion
2000-10-31
Completion
2003-03-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02488980 on ClinicalTrials.gov