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

Phase 2

Completed

• Conditions: Uncomplicated Diverticulitis
• Interventions: Drug: Rifamycin SV-MMX® 400 mg b.i.d.; Drug: Rifamycin SV-MMX® 600 mg t.i.d.; Drug: Rifamycin SV-MMX® Placebo

• Registration Number: NCT01847664
• Lead Sponsor: Dr. Falk Pharma GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-07
• Study Start: 2013-08
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1. Signed informed consent,
2. Patient is eligible for out-patient treatment,
3. Men or women between 18 and 80 years of age,
4. 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),
5. Presence of significant left lower quadrant pain during the last 24 hours before baseline,
6. CRP > ULN and/or leucocytosis (> ULN) at screening visit

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. Hemorrhagic diathesis,
7. Active peptic ulcer disease,
8. Abnormal hepatic function or liver cirrhosis,
9. Abnormal renal function,
10. Colorectal cancer or a history of colorectal cancer,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rifamycin SV-MMX® 400 mg b.i.d.	Rifamycin SV-MMX® 400 mg b.i.d.	Rifamycin SV-MMX® 800 mg
Rifamycin SV-MMX® 600 mg t.i.d.	Rifamycin SV-MMX® 600 mg t.i.d.	Rifamycin SV-MMX® 1800 mg
Rifamycin SV-MMX® Placebo	Rifamycin SV-MMX® Placebo	Rifamycin SV-MMX® placebo

Primary Outcome Measures

Name	Time	Method
Rate of patients with treatment success at the day 10 visit	10 days	Treatment success includes e.g.: * absence of diverticulitis related symptoms; * no complications of acute diverticulitis; * no hospitalisation due to acute diverticulitis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Evangelisches Krankenhaus Kalk; 🇩🇪 Cologne, Nordrhein-Westfalen, Germany