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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2017

Interventions

  • Drug: Rifamycin SV-MMX® 400 mg b.i.d.
  • Drug: Rifamycin SV-MMX® 600 mg t.i.d.
  • Drug: Rifamycin SV-MMX® Placebo

Arms, Groups and Cohorts

  • Experimental: Rifamycin SV-MMX® 400 mg b.i.d.
    • Rifamycin SV-MMX® 800 mg
  • Experimental: Rifamycin SV-MMX® 600 mg t.i.d.
    • Rifamycin SV-MMX® 1800 mg
  • Placebo Comparator: Rifamycin SV-MMX® Placebo
    • Rifamycin SV-MMX® placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • First visit with treatment success
    • Time Frame: 10 days
  • Rate of surgical intervention of acute diverticulitis
    • Time Frame: 10 days
  • Rate of hospitalisation due to acute diverticulitis
    • Time Frame: 10 days
  • Rate of occurrence of complicated diverticulitis
    • Time Frame: 10 days

Participating in This Clinical Trial

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,

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr. Falk Pharma GmbH
  • Provider of Information About this Clinical Study
    • Sponsor

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