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

July 25, 2017 updated by: Dr. Falk Pharma GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Cologne, Nordrhein-Westfalen, Germany, 51103
        • Evangelisches Krankenhaus Kalk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rifamycin SV-MMX® 400 mg b.i.d.
Rifamycin SV-MMX® 800 mg
Drug: Rifamycin SV-MMX® 400 mg b.i.d.
EXPERIMENTAL: Rifamycin SV-MMX® 600 mg t.i.d.
Rifamycin SV-MMX® 1800 mg
Drug: Rifamycin SV-MMX® 600 mg t.i.d.
PLACEBO_COMPARATOR: Rifamycin SV-MMX® Placebo
Rifamycin SV-MMX® placebo
Drug: Rifamycin SV-MMX® Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (ESTIMATE)

May 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIT-4/DIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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