NCT01847664
Completed
Phase 2
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
ConditionsUncomplicated Diverticulitis
Overview
- Phase
- Phase 2
- Intervention
- Rifamycin SV-MMX® 400 mg b.i.d.
- Conditions
- Uncomplicated Diverticulitis
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- Rate of patients with treatment success at the day 10 visit
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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,
Arms & Interventions
Rifamycin SV-MMX® 400 mg b.i.d.
Rifamycin SV-MMX® 800 mg
Intervention: Rifamycin SV-MMX® 400 mg b.i.d.
Rifamycin SV-MMX® 600 mg t.i.d.
Rifamycin SV-MMX® 1800 mg
Intervention: Rifamycin SV-MMX® 600 mg t.i.d.
Rifamycin SV-MMX® Placebo
Rifamycin SV-MMX® placebo
Intervention: Rifamycin SV-MMX® Placebo
Outcomes
Primary Outcomes
Rate of patients with treatment success at the day 10 visit
Time Frame: 10 days
Treatment success includes e.g.: * absence of diverticulitis related symptoms * no complications of acute diverticulitis * no hospitalisation due to acute diverticulitis
Secondary Outcomes
- 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)
- First visit with treatment success(10 days)
Study Sites (1)
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