Evaluation of Weekly Tafenoquine

Malaria Clinical Trial

Official title:

Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491606
• Other study ID #: A-7540
• Status: Completed
• Phase: Phase 2
• Start date: May 1997
• Est. completion date: September 1998

Study information

• Verified date: September 2018
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: September 1998
• Est. primary completion date: September 1997
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy subjects (male or female)

2. Age of 18-55 years

3. Residing in one of the study villages of the Nyanza Province for the entire study

Exclusion Criteria:

1. Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.

2. Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).

3. Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.

4. Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.

5. Known hypersensitivity to any study drug.

6. Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.

7. Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Tafenoquine
Tafenoquine 200mg and 400 mg

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	SmithKline Beecham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prophylactic outcome.	Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.; A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.	13 Weeks
Secondary	Prophylactic outcome after 7 weeks	Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.; A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.	7 Weeks
Secondary	Prophylactic outcome after 10 weeks	Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.; A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.	10 Weeks