A Randomized, Double-Blind, Safety and Tolerability Study to Assess the Ophthalmic and Renal Effects of Tafenoquine 200 mg Weekly versus Placebo for 6 Months in Healthy Volunteers
| العنوان: | A Randomized, Double-Blind, Safety and Tolerability Study to Assess the Ophthalmic and Renal Effects of Tafenoquine 200 mg Weekly versus Placebo for 6 Months in Healthy Volunteers |
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| المؤلفون: | Daoqin Bi, Louis R. Cantilena, D. Craig Brater, Michael J. Roy, Ronnie Beboso, Corina van de Pol, James M. Veazey, Michael A. Riel, Caron Kerr, Khadeeja Pruett, Colin Ohrt, Kevin J. Leary |
| المصدر: | The American Journal of Tropical Medicine and Hygiene. 81:356-362 |
| بيانات النشر: | American Society of Tropical Medicine and Hygiene, 2009. |
| سنة النشر: | 2009 |
| مصطلحات موضوعية: | medicine.medical_specialty, Randomization, Tafenoquine, business.industry, Renal function, Placebo, Surgery, law.invention, chemistry.chemical_compound, Infectious Diseases, chemistry, Randomized controlled trial, law, Virology, Night vision, Tolerability Study, Internal medicine, Medicine, Parasitology, Dosing, business |
| الوصف: | A randomized, double-blind, placebo-controlled study was conducted to assess the effect of tafenoquine, 200 mg weekly for 6 months on ophthalmic and renal safety. This trial was carried out after observations in previous clini- cal trials that tafenoquine may be associated with the development of corneal deposits and elevations in serum creatinine. In 120 healthy volunteers who received tafenoquine or placebo in a 2:1 randomization, there was no effect on night vision or other ophthalmic indices measured. Persons taking tafenoquine also showed no difference in mean change in glomeru- lar filtration rate (GFR, mL/s/1.73 m 2 ) after 6 months of dosing, with a treatment difference of �0.061 (95% confidence interval, �0.168, 0.045), and non-inferiority margin of �0.247 mL/s/1.73 m 2 . Tafenoquine was well tolerated over the course of the study. The results of this study showed no clinically significant effects of tafenoquine on ophthalmic or renal func- tion, and support its continued development as an antimalarial drug. |
| تدمد: | 1476-1645 0002-9637 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_________::b0440f3e21e6d888e45a356d0afabcefTest https://doi.org/10.4269/ajtmh.2009.81.356Test |
| رقم الانضمام: | edsair.doi...........b0440f3e21e6d888e45a356d0afabcef |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14761645 00029637 |
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