Trials / Completed
CompletedNCT01120340
Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- SOFAR S.p.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether mesalamine is effective vs. placebo in the prevention of diverticulitis flares in a 24-months follow-up. The primary end-point of the study is the incidence of diverticulitis flares. Will be made a clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and altered intestinal motility.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mesalamine | mesalamine: 1.6 g/die for ten days/month until 24 months |
| OTHER | placebo | 2 pills/day for ten days/month until 24 months |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2011-11-01
- Completion
- 2011-11-01
- First posted
- 2010-05-10
- Last updated
- 2013-09-18
Locations
17 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT01120340. Inclusion in this directory is not an endorsement.