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OpenTrials
Completed

NCT Number: NCT01847664

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Evangelisches Krankenhaus Kalk

Cologne, North Rhine-Westphalia, 51103, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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,

Treatment and study plan

Rifamycin SV-MMX® 400 mg b.i.d.

Drug

Rifamycin SV-MMX® 600 mg t.i.d.

Drug

Rifamycin SV-MMX® Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. First visit with treatment success

    Time frame: 10 days

  2. Rate of surgical intervention of acute diverticulitis

    Time frame: 10 days

  3. Rate of hospitalisation due to acute diverticulitis

    Time frame: 10 days

  4. Rate of occurrence of complicated diverticulitis

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 7, 2013
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.