At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 590 enrolled
Drug / intervention
SPD476 (1.2g) +3 moredrug
Likely dose
SPD476 (1.2g)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating SPD476 (1.2g), SPD476 (2.4 g), and 2 other interventions for Diverticulitis. Completed, enrolled 590 participants across 121 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiverticulitis
CountriesArgentina, Australia, Colombia, France, India, Israel, New Zealand, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartNov 2007
Primary CompletionMar 2012
TodayJul 2026
First PostedOct 17, 2007
Enrollment StartNov 28, 2007
Primary CompletionMar 5, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.7 years ago
Interventions
SPD476 (1.2g)drug
1.2g SPD476 once daily (QD) orally
SPD476 (2.4 g)drug
2.4g SPD476 QD orally
SPD476 (4.8 g)drug
4.8g SPD476 QD orally
Placebodrug
QD orally