MedTrace Logo

A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum

NCT02488902 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 521

Last updated 2018-09-13

No results posted yet for this study

Summary

This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as chemosuppression of P. falciparum malaria. Medications and placebo were matched and a double-dummy technique enabled blinding of tafenoquine versus mefloquine.

Conditions

Interventions

DRUG

Placebo

Placebo

DRUG

Tafenoquine 25mg

Tafenoquine 25mg

DRUG

Tafenoquine 50mg

Tafenoquine 50mg

DRUG

Tafenoquine 100 mg

Tafenoquine 100 mg

DRUG

Tafenoquine 200 mg

Tafenoquine 200 mg

DRUG

Mefloquine 250 mg

Mefloquine 250 mg

Sponsors & Collaborators

  • SmithKline Beecham

    collaborator INDUSTRY

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Braden Hale, MD · US Naval Medical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1998-08-31
Primary Completion
1998-09-30
Completion
2003-03-31

More Related Trials

Entities

Drugs
Diseases

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 NCT02488902 on ClinicalTrials.gov