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)
- Conditions
- Acute uncomplicated diverticulitisMedDRA version: 19.1Level: LLTClassification code 10055777Term: Diverticulitis of colon (without mention of haemorrhage)System Organ Class: 100000004862Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-003300-13-DE
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 375
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
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. Rifamycin SV-MMX® 600 mg t.i.d. vs. placebo, in patients with acute uncomplicated diverticulitis;Secondary Objective: •To assess the optimal dose of Rifamycin SV-MMX® for the treatment of acute uncomplicated diverticulitis<br>•To study safety and tolerability of Rifamycin SV-MMX® vs. placebo in terms of adverse events and laboratory parameters<br>;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 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<br>;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are included in the description of endpoints in E.5.2.