A comparative study on the efficacy of oral Rifamycin SV-MMX® 400 mg two times daily vs. Rifamycin SV-MMX® 600 mg three times daily vs. placebo (no active medication) in the treatment of acute uncomplicated diverticulitis (inflammation of protuberances of the bowel mucosa)

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 - Rifamycin 400 mg b.i.d. vs. Rifamycin 600 mg t.i.d. vs. placebo in the treatment of diverticulitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003300-13-HU

Enrollment

375

Registered

2012-12-20

Start date

2013-03-07

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute uncomplicated diverticulitis MedDRA version: 18.0 Level: LLT Classification code 10055777 Term: Diverticulitis of colon (without mention of haemorrhage) System Organ Class: 100000004862

Interventions

Product Name: Rifamycin SV-MMX® Pharmaceutical Form: Tablet INN or Proposed INN: Rifamycin Sodium CAS Number: 14897-39-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent, 2. Men or women between 18 and 80 years of age, 3. Diagnosis of left-sided uncomplicated diverticulitis 4. Conservative therapy/management indicated, no need for surgery or intervention Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 187 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 188

Exclusion criteria

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. Inability to tolerate oral intake

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: • To assess the optimal dose of Rifamycin SV-MMX® for the treatment of acute uncomplicated diverticulitis • To study safety and tolerability of Rifamycin SV-MMX® vs. placebo in terms of adverse events and laboratory parameters ;Primary end point(s): Rate of patients with treatment success at the day 10 visit;Timepoint(s) of evaluation of this end point: After 10 days of treatment	—

Measure

Time frame

Main Objective: 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;Secondary Objective: • To assess the optimal dose of Rifamycin SV-MMX® for the treatment of acute uncomplicated diverticulitis • To study safety and tolerability of Rifamycin SV-MMX® vs. placebo in terms of adverse events and laboratory parameters ;Primary end point(s): Rate of patients with treatment success at the day 10 visit;Timepoint(s) of evaluation of this end point: After 10 days of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): • Rate of treatment success at V3 and V4 • First visit with treatment success (V3, V4 or V5) • Rate of treatment failure at V3, V4 and V5 • First visit with treatment failure (V3, V4 or V5) • Rate of surgical intervention of acute diverticulitis until V5 and V6 • Rate of antimicrobial treatment due to acute diverticulitis until V5 and V6 • Rate of hospitalisation due to acute diverticulitis until V5 and V6 • Rate of occurrence of complicated diverticulitis until V5 and V6 • Use of rescue therapy until V5 ;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are included in the description of endpoints in E.5.2.	—

Measure

Time frame

Secondary end point(s): • Rate of treatment success at V3 and V4 • First visit with treatment success (V3, V4 or V5) • Rate of treatment failure at V3, V4 and V5 • First visit with treatment failure (V3, V4 or V5) • Rate of surgical intervention of acute diverticulitis until V5 and V6 • Rate of antimicrobial treatment due to acute diverticulitis until V5 and V6 • Rate of hospitalisation due to acute diverticulitis until V5 and V6 • Rate of occurrence of complicated diverticulitis until V5 and V6 • Use of rescue therapy until V5 ;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are included in the description of endpoints in E.5.2.

—

Countries

Germany, Hungary, Latvia, Lithuania, Romania, Slovakia

Contacts

Public ContactDept. of Clin. Res. & Development

Dr. Falk Pharma GmbH

zentrale@drfalkpharma.de+4976115140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 17, 2026