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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01847664
First Posted: May 7, 2013
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
  Purpose
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.

Condition Intervention Phase
Uncomplicated Diverticulitis Drug: Rifamycin SV-MMX® 400 mg b.i.d. Drug: Rifamycin SV-MMX® 600 mg t.i.d. Drug: Rifamycin SV-MMX® Placebo Phase 2

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

Resource links provided by NLM:


Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome 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 Outcome 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 ]

Enrollment: 204
Study Start Date: August 2013
Study Completion Date: July 2017
Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847664


Locations
Germany
Evangelisches Krankenhaus Kalk
Cologne, Nordrhein-Westfalen, Germany, 51103
Sponsors and Collaborators
Dr. Falk Pharma GmbH
  More Information

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01847664     History of Changes
Other Study ID Numbers: RIT-4/DIV
First Submitted: April 26, 2013
First Posted: May 7, 2013
Last Update Posted: July 26, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Diverticulitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rifamycins
Rifamycin SV
Anti-Bacterial Agents
Anti-Infective Agents
Antirheumatic Agents