SPD476 (1.2g)
Drug1.2g SPD476 once daily (QD) orally
Other names: Lialda, MMX™ mesalazine
NCT Number: NCT00545740
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
CIMEL, Lanus, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.2g SPD476 once daily (QD) orally
Other names: Lialda, MMX™ mesalazine
2.4g SPD476 QD orally
Other names: Lialda, MMX™ mesalazine
4.8g SPD476 QD orally
Other names: Lialda, MMX™ mesalazine
QD orally
Time frame: Up to 104 weeks
Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.
Time frame: Up to 104 weeks
CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.
Time frame: Up to 104 weeks
A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.
Time frame: Up to 104 weeks
A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.
Time frame: Up to 104 weeks
A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.
Time frame: Up to 104 weeks
A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.
Time frame: Up to 104 weeks
Shire
Industry
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.
Acronym: PREVENT1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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