NCT02488902

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

A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum in Semi-immune Adults Living in the Kassena-Nankana District of Northern Ghana

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 521 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

• Malaria

Interventions

Type	Name	Description
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

Timeline

• Start date: 1998-08-01
• Primary completion: 1998-09-01
• Completion: 2003-03-01
• First posted: 2015-07-02
• Last updated: 2018-09-13