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| Name | Class |
|---|---|
| SmithKline Beecham | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
|
| Tafenoquine 25mg | Experimental | Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
|
| Tafenoquine 50mg | Experimental | Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
|
| Tafenoquine 100 mg | Experimental | Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
|
| Tafenoquine 200 mg | Experimental | Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| Tafenoquine 25mg |
| Measure | Description | Time Frame |
|---|---|---|
| First occurrence of malaria infection | First occurrence of malaria infection as documented by a positive malaria smear. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to confirmation of parasitaemia | Time to confirmation of parasitaemia as documented by two consecutive positive smears and the incidence density of parasitaemia. | 16 weeks |
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Inclusion Criteria:
Willing subjects in good general health.
Exclusion Criteria:
Subjects with any cardiovascular, liver, neurologic, or renal function abnormality which, in the opinion of the clinical investigators, would have placed them at increased risk of an adverse event or confused the result.
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| Name | Affiliation | Role |
|---|---|---|
| Braden Hale, MD | US Naval Medical Research Unit | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28495354 | Derived | Novitt-Moreno A, Ransom J, Dow G, Smith B, Read LT, Toovey S. Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis. Travel Med Infect Dis. 2017 May-Jun;17:19-27. doi: 10.1016/j.tmaid.2017.05.008. Epub 2017 May 8. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 7, 2018 | |
| Reset | Mar 5, 2019 | |
| Release | May 11, 2020 |
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| Mefloquine 250 mg | Experimental | Mefloquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
|
| Drug |
Tafenoquine 25mg |
|
| Tafenoquine 50mg | Drug | Tafenoquine 50mg |
|
| Tafenoquine 100 mg | Drug | Tafenoquine 100 mg |
|
| Tafenoquine 200 mg | Drug | Tafenoquine 200 mg |
|
| Mefloquine 250 mg | Drug | Mefloquine 250 mg |
|
| Reset | May 20, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 7, 2018 | Mar 5, 2019 | |||
| May 11, 2020 | May 20, 2020 |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| C055852 | tafenoquine |
| D015767 | Mefloquine |
| ID | Term |
|---|---|
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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