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临床试验/NCT00683865
NCT00683865已完成3 期

Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)

Bayer0 个研究点目标入组 749 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Bayer
入组人数
749
主要终点
Clinical response 5 to 24 days after the last dose of study medication

研究概览

简要总结

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness;
  • Adnexal tenderness on bimanual vaginal examination,
  • Temperature > 38.0°C; - Elevated C-reactive protein value (CRP);
  • Signed PIC/IC

排除标准

  • Pregnancy
  • Abnormal lab values

研究组 & 干预措施

Arm 1

Active Comparator

干预措施: Ofloxacin (Drug)

Arm 2

Experimental

干预措施: Avelox (Moxifloxacin, BAY12-8039) (Drug)

结局指标

主要结局

Clinical response 5 to 24 days after the last dose of study medication

时间窗: 5 to 24 days after the last dose

次要结局

  • Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication(visit 28 to 42 days after last dose)
  • Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose((Day 4-7) and at follow-up 28 to 42 days after last dose)
  • Reduction from baseline in pain report at the different assessment visits(Over the entire trial period (overall))
  • Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up(Over the entire trial period (overall))

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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