Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02216123 |
Recruitment Status :
Completed
First Posted : August 13, 2014
Results First Posted : May 16, 2018
Last Update Posted : May 16, 2018
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Sponsor:
GlaxoSmithKline
Collaborator:
Medicines for Malaria Venture
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Malaria, Vivax |
Interventions |
Drug: Tafenoquine Drug: Tafenoquine Placebo Drug: Chloroquine Drug: Primaquine Drug: Primaquine Placebo |
Enrollment | 251 |
Participant Flow
Recruitment Details | This is a randomized, double-blind, double-dummy, comparative, multicenter study to assess the incidence of hemolysis, safety and efficacy of Tafenoquine (TQ) versus Primaquine (PQ) in treatment of participants with Plasmodium vivax (P. vivax) malaria. |
Pre-assignment Details | A total of 369 participants were screened of which 118 failed screening and 251 participants were randomized to receive either TQ+chloroquine (CQ) or PQ+CQ in a ratio of 2:1. |
Arm/Group Title | TQ+CQ | PQ+CQ |
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Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration. | Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration. |
Period Title: Overall Study | ||
Started | 166 | 85 |
Completed | 160 | 83 |
Not Completed | 6 | 2 |
Reason Not Completed | ||
Lost to Follow-up | 4 | 2 |
Withdrawal by Subject | 2 | 0 |
Baseline Characteristics
Arm/Group Title | TQ+CQ | PQ+CQ | Total | |
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Participants were administered CQ 600 milligram (mg) once daily on Days 1 and 2 and CQ 300 mg on Day 3. A single dose of TQ 300 mg was administered orally on Day 1 or Day 2. PQ placebo capsules were administered orally once daily for 14 days starting on the same day as TQ administration. | Participants were administered CQ 600 mg tablet once daily on Days 1 and 2 and CQ 300 mg on Day 3. Participants received a single TQ placebo tablet orally on Day 1 or Day 2. PQ 15 mg was administered orally once daily for 14 days starting on the same day as TQ placebo administration. | Total of all reporting groups | |
Overall Number of Baseline Participants | 166 | 85 | 251 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 166 participants | 85 participants | 251 participants | |
37.5 (14.28) | 37.7 (14.69) | 37.6 (14.39) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 166 participants | 85 participants | 251 participants | |
Female |
52 31.3%
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32 37.6%
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84 33.5%
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Male |
114 68.7%
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53 62.4%
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167 66.5%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Count of Participants |
Number Analyzed | 166 participants | 85 participants | 251 participants |
American (Amer) Indian (Ind) or Alaska Native (N) | 87 | 43 | 130 | |
Asian-East Asian Heritage | 6 | 3 | 9 | |
Asian-South East Asian Heritage | 35 | 20 | 55 | |
Black or African Amer | 2 | 0 | 2 | |
African Amer/African Heritage/Amer Ind or Alaska N | 36 | 19 | 55 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT02216123 |
Other Study ID Numbers: |
116564 |
First Submitted: | June 19, 2014 |
First Posted: | August 13, 2014 |
Results First Submitted: | November 1, 2017 |
Results First Posted: | May 16, 2018 |
Last Update Posted: | May 16, 2018 |