Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis
NCT ID: NCT01847664
Last Updated: 2017-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2013-08-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rifamycin SV-MMX® 400 mg b.i.d.
Rifamycin SV-MMX® 800 mg
Rifamycin SV-MMX® 400 mg b.i.d.
Rifamycin SV-MMX® 600 mg t.i.d.
Rifamycin SV-MMX® 1800 mg
Rifamycin SV-MMX® 600 mg t.i.d.
Rifamycin SV-MMX® Placebo
Rifamycin SV-MMX® placebo
Rifamycin SV-MMX® Placebo
Interventions
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Rifamycin SV-MMX® 400 mg b.i.d.
Rifamycin SV-MMX® 600 mg t.i.d.
Rifamycin SV-MMX® Placebo
Eligibility Criteria
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Inclusion Criteria
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
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,
18 Years
80 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Locations
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Evangelisches Krankenhaus Kalk
Cologne, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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RIT-4/DIV
Identifier Type: -
Identifier Source: org_study_id
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