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

• Sponsor: Dr. Falk Pharma GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01847664
• Collaborator: (none)
• Enrollment: 204
• Location: 1
• Arms: 3
• Duration (Months): 47
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	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 Design

• Study Type: Interventional
• Actual Enrollment: 204 participants
• 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
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rate of patients with treatment success at the day 10 visit [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

1. First visit with treatment success [10 days]

2. Rate of surgical intervention of acute diverticulitis [10 days]

3. Rate of hospitalisation due to acute diverticulitis [10 days]

4. Rate of occurrence of complicated diverticulitis [10 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Evangelisches Krankenhaus Kalk	Cologne	Nordrhein-Westfalen	Germany	51103

Sponsors and Collaborators

• Dr. Falk Pharma GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Falk Pharma GmbH
• ClinicalTrials.gov Identifier: NCT01847664
• Other Study ID Numbers: RIT-4/DIV
• First Posted: May 7, 2013
• Last Update Posted: Jul 26, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Diverticulitis; Rifamycins; Rifamycin SV

Study Results

No Results Posted as of Jul 26, 2017