NCT01847664已完成2 期
A Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy of Oral Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in the Treatment of Acute Uncomplicated Diverticulitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Rate of patients with treatment success at the day 10 visit
研究概览
简要总结
The purpose of the trial is to compare the efficacy of Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. placebo in patients with acute uncomplicated diverticulitis.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent,
- •Patient is eligible for out-patient treatment,
- •Men or women between 18 and 80 years of age,
- •Diagnosis of left-sided uncomplicated diverticulitis confirmed by ultrasonography (US) and/or computed tomography (CT) according to modified Hinchey classification (stage 1a) or Hansen/Stock classification (stage I/IIa) or Ambrosetti classification (stage mild),
- •Presence of significant left lower quadrant pain during the last 24 hours before baseline,
- •CRP > ULN and/or leucocytosis (> ULN) at screening visit
排除标准
- •Existing complications of diverticulitis (diverticulitis with associated abscess, fistula, obstruction or perforation),
- •Right-sided diverticulitis,
- •Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),
- •Chronic inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or celiac disease,
- •Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia),
- •Hemorrhagic diathesis,
- •Active peptic ulcer disease,
- •Abnormal hepatic function or liver cirrhosis,
- •Abnormal renal function,
- •Colorectal cancer or a history of colorectal cancer,
研究组 & 干预措施
Rifamycin SV-MMX® 400 mg b.i.d.
Experimental
Rifamycin SV-MMX® 800 mg
干预措施: Rifamycin SV-MMX® 400 mg b.i.d. (Drug)
Rifamycin SV-MMX® 600 mg t.i.d.
Experimental
Rifamycin SV-MMX® 1800 mg
干预措施: Rifamycin SV-MMX® 600 mg t.i.d. (Drug)
Rifamycin SV-MMX® Placebo
Placebo Comparator
Rifamycin SV-MMX® placebo
干预措施: Rifamycin SV-MMX® Placebo (Drug)
结局指标
主要结局
Rate of patients with treatment success at the day 10 visit
时间窗: 10 days
Treatment success includes e.g.: * absence of diverticulitis related symptoms * no complications of acute diverticulitis * no hospitalisation due to acute diverticulitis
次要结局
- Rate of surgical intervention of acute diverticulitis(10 days)
- Rate of hospitalisation due to acute diverticulitis(10 days)
- Rate of occurrence of complicated diverticulitis(10 days)
- First visit with treatment success(10 days)
研究者
研究点 (1)
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