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)

Phase 1

Active, not recruiting

• Conditions: Acute uncomplicated diverticulitis; MedDRA version: 15.1Level: LLTClassification code 10055777Term: Diverticulitis of colon (without mention of haemorrhage)System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-003300-13-IT
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-04
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 375

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to compare the efficacy of Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifacyn SV-MMX® 600 mg t.i.d. vs. placebo, in patients with acute uncomplicated diverticulitis ;Secondary Objective: To compare the efficacy of Rifamycin SV-MMX® 400 mg b.i.d. vs.<br>Rifamycin SV-MMX® 600 mg t.i.d. vs. placebo, in patients with acute<br>uncomplicated diverticulitis;Primary end point(s): rate of patients with treatment success at the day 10 visit;Timepoint(s) of evaluation of this end point: after 10 days of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): · Rate of treatment success at V3 and V4<br>· First visit with treatment success (V3, V4 or V5)<br>· Rate of treatment failure at V3, V4 and V5<br>· First visit with treatment failure (V3, V4 or V5)<br>· Rate of surgical intervention of acute diverticulitis until V5 and V6<br>· Rate of antimicrobial treatment due to acute diverticulitis until V5 and<br>V6<br>· Rate of hospitalisation due to acute diverticulitis until V5 and V6<br>· Rate of occurrence of complicated diverticulitis until V5 and V6<br>· Use of rescue therapy until V5;Timepoint(s) of evaluation of this end point: timepoints of evaluation are included in the description of endpoints in E.5.2