跳至主要内容
临床试验/EUCTR2012-003300-13-SK
EUCTR2012-003300-13-SK进行中(未招募)1 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 - Rifamycin 400 mg b.i.d. vs. Rifamycin 600 mg t.i.d. vs. placebo in the treatment of diverticulitis

Dr. Falk Pharma GmbH0 个研究点目标入组 375 人开始时间: 2015年1月29日最近更新:

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

相似试验

进行中(未招募)
1 期
A comparative study on the efficacy of oral Rifamycin SV-MMX® 400 mg two times daily vs Rifamycin SV-MMX® 600 mg b.i.d. three times daily vs placebo (no active medication) in the treatment of acute uncomplicated diverticulitis (inflammation of protuberances of the bowel mucosa)
EUCTR2012-003300-13-ITDr. Falk Pharma GmbH375
进行中(未招募)
1 期
A comparative study on the efficacy of oral Rifamycin SV-MMX® 400 mg two times daily vs. Rifamycin SV-MMX® 600 mg three times daily vs. placebo (no active medication) in the treatment of acute uncomplicated diverticulitis (inflammation of protuberances of the bowel mucosa)
EUCTR2012-003300-13-RODr. Falk Pharma GmbH201
进行中(未招募)
1 期
A comparative study on the efficacy of oral Rifamycin SV-MMX® 400 mg two times daily vs. Rifamycin SV-MMX® 600 mg three times daily vs. placebo (no active medication) in the treatment of acute uncomplicated diverticulitis (inflammation of protuberances of the bowel mucosa)
EUCTR2012-003300-13-LVDr. Falk Pharma GmbH375
进行中(未招募)
1 期
A comparative study on the efficacy of oral Rifamycin SV-MMX® 400 mg two times daily vs. Rifamycin SV-MMX® 600 mg three times daily vs. placebo (no active medication) in the treatment of acute uncomplicated diverticulitis (inflammation of protuberances of the bowel mucosa)
EUCTR2012-003300-13-DEDr. Falk Pharma GmbH375
进行中(未招募)
1 期
A comparative study on the efficacy of oral Rifamycin SV-MMX® 400 mg two times daily vs. Rifamycin SV-MMX® 600 mg three times daily vs. placebo (no active medication) in the treatment of acute uncomplicated diverticulitis (inflammation of protuberances of the bowel mucosa)Acute uncomplicated diverticulitisMedDRA version: 19.0Level: LLTClassification code 10055777Term: Diverticulitis of colon (without mention of haemorrhage)System Organ Class: 100000004862
EUCTR2012-003300-13-LTDr. Falk Pharma GmbH375