Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Uncomplicated Diverticulitis

Intervention / Treatment
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* Drug: Rifamycin SV-MMX® 400 mg b.i.d.
* Drug: Rifamycin SV-MMX® 600 mg t.i.d.
* Drug: Rifamycin SV-MMX® Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifamycin SV-MMX® 400 mg b.i.d.<br>Rifamycin SV-MMX® 800 mg | Drug: Rifamycin SV-MMX® 400 mg b.i.d.<br> <br> |
| Experimental: Rifamycin SV-MMX® 600 mg t.i.d.<br>Rifamycin SV-MMX® 1800 mg | Drug: Rifamycin SV-MMX® 600 mg t.i.d.<br> <br> |
| Placebo Comparator: Rifamycin SV-MMX® Placebo<br>Rifamycin SV-MMX® placebo | Drug: Rifamycin SV-MMX® Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with treatment success at the day 10 visit | Treatment success includes e.g.: absence of diverticulitis related symptoms no complications of acute diverticulitis no hospitalisation due to acute diverticulitis | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First visit with treatment success |  | 10 days | 
| 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 |