EUCTR2012-003300-13-IT进行中（未招募）1 期
A randomised, double-blind, double-dummy, multi-centre, comparative parallel-group study to evaluate the eficacy 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 - Rifamycin 400 mg b.i.d. vs Rifamycin 600 mg t.i.d. vs placebo in the treatment of diverticulitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 375
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent,
- •2. Men or women between 18 and 80 years of age,
- •3. Diagnosis of left-sided uncomplicated diverticulitis
- •4. Conservative therapy/management indicated, no need for surgery or
- •intervention,
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 187
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 188
排除标准
- •1. Existing complications of diverticulitis (diverticulitis with associated
- •abscess, fistula, obstruction or perforation),
- •2. Right-sided diverticulitis,
- •3. Previous colonic surgery (except appendectomy, haemorrhoidectomy,
- •and endoscopic removal of polyps),
- •4. Chronic inflammatory bowel disease (such as Crohn`s disease,
- •ulcerative colitis) or celiac disease,
- •5. Presence of symptomatic organic disease of the gastrointestinal tract
- •(with the exception of non-bleeding hemorrhoids or hiatal hernia),
- •6. Inability to tolerate oral intake.
研究者
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