Trials / Terminated
TerminatedNCT03469050
Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.
Rifaximin Delayed Release (400 mg Tablet) for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications. A Phase II, Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 193 (actual)
- Sponsor
- Alfasigma S.p.A. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rifaximin delayed released 400mg Tablet | Rifaximin delayed released |
| OTHER | Placebo | Placebo BID + Placebo BID |
Timeline
- Start date
- 2018-07-02
- Primary completion
- 2020-12-22
- Completion
- 2020-12-22
- First posted
- 2018-03-19
- Last updated
- 2021-10-20
Locations
64 sites across 6 countries: France, Germany, Italy, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03469050. Inclusion in this directory is not an endorsement.