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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
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.
Details
| Lead sponsor | Dr. Falk Pharma GmbH |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 204 |
| Start date | 2013-08 |
| Completion | 2017-07 |
Conditions
- Uncomplicated Diverticulitis
Interventions
- Rifamycin SV-MMX® 400 mg b.i.d.
- Rifamycin SV-MMX® 600 mg t.i.d.
- Rifamycin SV-MMX® Placebo
Primary outcomes
- 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
Countries
Germany