Status:
COMPLETED
Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Uncomplicated Diverticulitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT01847664
Start Date
August 1 2013
End Date
July 1 2017
Last Update
July 26 2017
Active Locations (1)
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1
Evangelisches Krankenhaus Kalk
Cologne, North Rhine-Westphalia, Germany, 51103