Safety and Efficacy of WC2031 Versus Vibramycin for the Treatment of Uncomplicated Urogenital Chlamydia Trachomatis Infection: A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- Microbiological Cure Rate
研究概览
简要总结
Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary efficacy endpoint is microbiological cure at Day 28. Safety assessments are adverse events, changes in vital signs and laboratory test results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-45 years of age, male or female
- •presumed diagnosis of urogenital C. trachomatis infection
- •use condoms during sexual activity during study (enrollment thru day 28)
排除标准
- •Clinical diagnosis pelvic inflammatory disease or epididymitis at baseline
- •Diagnosis of N. gonorrhoea
- •HIV infection
- •Active Hepatitis B or C infection
- •Prior hysterectomy (partial or total)
- •Treatment with antimicrobial therapy with known activity against urogenital C. trachomatis within 28 days of enrollment
研究组 & 干预措施
Doxycycline Hyclate 200 mg tablet
Once daily
干预措施: Doxycyline Hyclate tablet (Drug)
Vibramycin 100 mg capsule
Twice daily
干预措施: Vibramycin (doxycyline hyclate) capsule (Drug)
结局指标
主要结局
Microbiological Cure Rate
时间窗: Day 28
Percentage of Subjects in mITT Population with Microbiological Cure defined as a negative result for C. trachomatis as determined by GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test) at Day 28
次要结局
- Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured(End of Study (Day 28))
- Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured(End of Study (Day 28))
- Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured(Day 28)