EUCTR2012-003300-13-LVActive, not recruitingPhase 1
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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 375
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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