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

Uncomplicated Diverticulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847664
• Other study ID #: RIT-4/DIV
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2013
• Last updated: July 25, 2017
• Start date: August 2013
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Diverticulitis
• Uncomplicated Diverticulitis

Intervention

Drug:
• Rifamycin SV-MMX® 400 mg b.i.d.

• Rifamycin SV-MMX® 600 mg t.i.d.

• Rifamycin SV-MMX® Placebo

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus Kalk	Cologne	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First visit with treatment success		10 days
Secondary	Rate of surgical intervention of acute diverticulitis		10 days
Secondary	Rate of hospitalisation due to acute diverticulitis		10 days
Secondary	Rate of occurrence of complicated diverticulitis		10 days