drugset / Trial / NCT03469050

Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.

NCT03469050

Phase 2/3 Terminated 193 enrolled Alfasigma S.p.A.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Colonic microbiota changes may play a key role in the pathogenesis of acute diverticulitis. A previous proof-of-concept study suggests that rifaximin, a low-absorbable oral antibiotic, may be beneficial for prevention of acute diverticulitis recurrence by modulating the gut microflora. The main objective of this study is to evaluate the safety and efficacy of two different doses of a delayed release formulation of rifaximin, versus placebo, for the prevention of recurrence of acute diverticulitis and diverticular complications in patients with a recent episode of acute diverticulitis.

Timeline

Start
2018-07-02
Primary completion
2020-12-22
Completion
2020-12-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifaximin Other / unclassified 400 mg Oral
Subject Rifaximin Other / unclassified 800 mg Oral

Indications