Trials / Completed
CompletedNCT00545740
Prevention of Recurrence of Diverticulitis
A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 590 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPD476 (1.2g) | 1.2g SPD476 once daily (QD) orally |
| DRUG | SPD476 (2.4 g) | 2.4g SPD476 QD orally |
| DRUG | SPD476 (4.8 g) | 4.8g SPD476 QD orally |
| DRUG | Placebo | QD orally |
Timeline
- Start date
- 2007-11-28
- Primary completion
- 2012-03-05
- Completion
- 2012-03-05
- First posted
- 2007-10-17
- Last updated
- 2021-06-14
- Results posted
- 2013-01-25
Locations
121 sites across 11 countries: United States, Argentina, Australia, Colombia, France, India, Israel, New Zealand, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00545740. Inclusion in this directory is not an endorsement.