jRCT2031220181已完成不适用
A phase III confirmatory study of KLH-2109 in uterine fibroids patient with menorrhagia and pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 主要终点
- Proportion of subjects with a maximum NRS for pain score of 1 or less
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- Female
入选标准
- •Japanese uterine fibroid patients
- •Premenopausal female patient over 20 years old
- •Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:
- •Larger than a certain standard
- •No calcification
- •Not receiving surgical treatment
- •Patients with a normal menstrual cycle
- •Patients diagnosed with menorrhagia
- •Patients with pain symptoms associated with uterine fibroids
排除标准
- •Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
- •Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis
- •Patients with undiagnosed abnormal genital bleeding
结局指标
主要结局
Proportion of subjects with a maximum NRS for pain score of 1 or less
时间窗: 28 days before the end of study drug administration
Proportion of subjects with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration
Proportion of subjects with a total PBAC score of less than 10
时间窗: Week 6 to 12 after beginning of study drug administration
Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration
次要结局
- Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6(Week 2 to 6 after beginning of study drug administration)
- Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end(6 weeks before end of study drug administration)
- Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days(every 28 days)
- Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end(28 days before end of study drug administration)
- Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days(every 28 days)
- Average NRS score every 28 days for pain symptoms(every 28 days)
- Percentage of asymptomatic days during 28 days before end(28 days before end of study drug administration)
- Percentage of asymptomatic days every 28 days(every 28 days)
- Incidence of adverse events and adverse drug reactions
- Changes and fluctuations from baseline in laboratory tests
- Changes and fluctuations from baseline in vital signs
- Changes and fluctuations from baseline in body weight
- Changes and fluctuations from baseline in parameters of 12-lead ECG
研究者
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