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 201 人开始时间: 2014年7月28日最近更新: 2022年1月17日

试验速览

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•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

•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

发起方