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English英语译成Chinese汉语: 联合用药治疗痛风石性痛风临床试验 General field: 医学
原文文本 - English英语 SYNOPSIS
Study Title:
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects with Tophaceous Gout
Primary Objective:
• To determine the efficacy of lesinurad by Month 6 when used in combination with febuxostat compared to febuxostat monotherapy
Secondary Objectives:
• To determine the efficacy of lesinurad by Month 12 when used in combination with febuxostat compared to febuxostat monotherapy
• To determine the safety of lesinurad over 6 months and 12 months when used in combination with febuxostat
• To investigate by a population analysis approach the influence of intrinsic factors (age, sex, race, body weight, renal function, concomitant medication use) on oral clearance of lesinurad
• To determine the effect of lesinurad when used in combination with febuxostat on Health Related Quality of Life and physical function
Test Product; Dose; and Mode of Administration:
Lesinurad 200 mg or 400 mg tablets will be supplied to all randomized subjects. Febuxostat 80 mg tablets will be supplied to all qualified subjects beginning approximately 21 days before the Day 1 (Baseline) Visit.
All doses of lesinurad should be taken in the morning with food and one cup of water.
The dose and dosing regimen of febuxostat should not be changed during the course of this study except for safety reasons. It is recommended that the morning dose of febuxostat be taken at the same time as lesinurad.
Efficacy Assessments:
Endpoints
Primary:
• Proportion of subjects with an sUA level that is < 5.0 mg/dL by Month 6
Key secondary endpoints include:
1. Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12
2. Proportion of subjects with a best tophus response on at least 1 target tophus of complete or partial resolution by Month 12
3. Proportion of subjects with an improvement from Baseline in HAQ-DI of at least 0.25 at Month 12
Safety Assessments:
Safety assessments will include adverse events (AEs), previous and concomitant therapies, medical and surgical history, laboratory data except sUA results, urinalysis data, compliance with study medications, physical exam, ECG, and vital signs.
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Hello, my name is Shawn and I am a English-Chinese bilingual biopharmaceutical professional skilled in providing linguistics expertise on a wide variety of contents including life sciences, biotechnology, medicine, veterinary medicine and pharmaceuticals.
I am a native Chinese and now working in a biotechnology company in the United States as scientist. I have PhD in biology and bachelor's degree in veterinary medicine. I am a part-time freelance translator associated with multiple translation and localization company such as TransPerfect, Asian Absolute, Translated etc.
With high work ethic and standard for my work product, I am good at multitask and able to work fast and efficient while yet delivering a high quality and accurate work product.
Look forward to the opportunity to work with anybody who need English<>Chinese translation service.
关键词： English, Chinese, Localization, life sciences, biology, medicine, biotechnology, pharmaceutical industry, veterinary medicine
