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. (see Contacts and Locations)
Verified May 2014 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: May 14, 2014
Last verified: May 2014
  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 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diverticulitis
Intraabdominal Infections
Infection
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 August 21, 2014