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 is currently recruiting participants.
Verified September 2013 by Dr. Falk Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01847664
First received: April 26, 2013
Last updated: September 2, 2013
Last verified: September 2013
  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®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ]

Estimated Enrollment: 375
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Rifamycin SV-MMX® 400 mg b.i.d.
Drug: Rifamycin SV-MMX®
Experimental: B
Rifamycin SV-MMX® 600 mg t.i.d.
Drug: Rifamycin SV-MMX®
Placebo Comparator: C
Rifamycin SV-MMX® placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01847664

Contacts
Contact: Tanju Nacak, Dr. +49 (0)761 1514 ext 187 nacak@drfalkpharma.de

Locations
Germany
Evangelisches Krankenhaus Kalk Recruiting
Cologne, Nordrhein-Westfalen, Germany, 51103
Contact: Wolgang Kruis, Prof. Dr.    +49 (0)221 8289 ext 5289    kruis@evkk.de   
Sponsors and Collaborators
Dr. Falk Pharma GmbH
  More Information

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01847664     History of Changes
Other Study ID Numbers: RIT-4/DIV
Study First Received: April 26, 2013
Last Updated: September 2, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rifamycins
Rifamycin SV
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014