At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 592 enrolled
Drug / intervention
SPD476, MMX™ mesalazine, 1.2g extended release tablet +3 moredrug
Likely dose
SPD476, MMX™ mesalazine, 1.2g extended release tabletfrom 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, MMX™ mesalazine, 1.2g extended release tablet, SPD476, MMX™ mesalazine, 2.4g extended release tablet, and 2 other interventions for Diverticulitis. Completed, enrolled 592 participants across 131 sites in 10 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
CountriesBrazil, Canada, Finland, Germany, Hungary, Italy, Netherlands, Romania, South Africa, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartDec 2007
Primary CompletionNov 2011
TodayJul 2026
First PostedOct 17, 2007
Enrollment StartDec 6, 2007
Primary CompletionNov 28, 2011
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 18.7 years ago
Interventions
SPD476, MMX™ mesalazine, 1.2g extended release tabletdrug
SPD476 1.2g administered Once Daily (QD)
SPD476, MMX™ mesalazine, 2.4g extended release tabletdrug
SPD476 2.4g administered Once Daily (QD)
SPD476, MMX™ mesalazine, 4.8g extended release tabletdrug
SPD476 4.8g administered Once Daily (QD)
Placebodrug
Placebo administered Once Daily (QD)