CompletedNCT01847664Updated Jul 26, 2017

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

A Phase 2 interventional study of Rifamycin SV-MMX® 400 mg b.i.d. and Rifamycin SV-MMX® 600 mg t.i.d. in Uncomplicated Diverticulitis, sponsored by Dr. Falk Pharma GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-26.

Sponsored by Dr. Falk Pharma GmbH · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 204
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Uncomplicated Diverticulitis

Browse trials for

Diverticulitis 146

In context

Diverticulitis

146 studies on the registry are indexed under Diverticulitis; 26 are open to participants now.

This study's enrollment of 204 is above the median of 120 across 71 interventional studies indexed under Diverticulitis.

Browse Diverticulitis studies →

Lead sponsor

Dr. Falk Pharma GmbH is the lead sponsor of 38 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Signed informed consent,
Patient is eligible for out-patient treatment,
Men or women between 18 and 80 years of age,
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),
Presence of significant left lower quadrant pain during the last 24 hours before baseline,
CRP > ULN and/or leucocytosis (> ULN) at screening visit

Exclusion criteria

Exclusion Criteria:

Existing complications of diverticulitis (diverticulitis with associated abscess, fistula, obstruction or perforation),
Right-sided diverticulitis,
Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),
Chronic inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or celiac disease,
Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia),
Hemorrhagic diathesis,
Active peptic ulcer disease,
Abnormal hepatic function or liver cirrhosis,
Abnormal renal function,
Colorectal cancer or a history of colorectal cancer,

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 204 participants (actual)

Study arms

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

Interventions

DrugRifamycin SV-MMX® 400 mg b.i.d.
DrugRifamycin SV-MMX® 600 mg t.i.d.
DrugRifamycin SV-MMX® Placebo

What researchers measure

Primary outcomes

Rate of patients with treatment success at the day 10 visit
Treatment success includes e.g.: * absence of diverticulitis related symptoms * no complications of acute diverticulitis * no hospitalisation due to acute diverticulitis
Time frame: 10 days

Secondary outcomes

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

Study locations

1 site

Evangelisches Krankenhaus Kalk
Cologne, Nordrhein-Westfalen 51103, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01847664
Lead sponsor: Dr. Falk Pharma GmbH
Responsible party: Sponsor
First posted: May 7, 2013
Start date: Aug 2013
Primary completion: Jul 2017
Completion: Jul 2017
Last update: Jul 26, 2017

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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