A clinical trial to study the safety and efficacy of mesalazine (5-ASA) in patients with a history of diverticulitis over 104 weeks

INTERVENTION: Intervention1: SPD476 contains 1.2g of the active ingredient mesalazine (5‐ASA): Each tablet will be administered orally, once a day. Subjects in the SPD476 treatment arms will receive: 1.2g SPD476/day QD (one 1.2g tablet + three matching placebo tablets per day) or 2.4g SPD476/day QD (two 1.2g tablets + two matching placebo tablets per day) or 4.8g SPD476/day QD (four 1.2g tablets per day) Control Intervention1: Placebo: The placebo arm will receive 4 matching placebo SPD476 tablets per day QD. CONDITION: Recurrence of Diverticulitis PRIMARY OUTCOME: Time to recurrence of diverticulitis‐‐‐‐‐‐Timepoint: between each of the 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD in subjects who have had at least one previous attack of diverticulitis; SECONDARY OUTCOME: 1.To compare the proportion of subjects without recurrence of diverticulitis‐‐‐‐‐‐Timepoint: at Weeks 26, 52 and 104 between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD; 2.To compare the proportion of subjects with recurrence of complicated versus; uncomplicated diverticulitis‐‐‐‐‐‐Timepoint: between each of 3 doses of SPD476 (1.2g/day QD,2.4g/day QD, and 4.8g/day QD) and placebo QD; 3.To compare the proportion of subjects requiring surgical intervention for diverticular disease‐‐‐‐‐‐Timepoint: between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD; 4. To compare QoL using the EQ5D and HUI2 questionnaires between treatment groups‐‐‐‐‐‐Timepoint: at Baseline, Weeks 16, 52, 78, and 104 between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD; 5. To assess the safety and tolerability of SPD476 1.2g/day QD, 2.4g/day QD, and 4.8g/day QD‐‐‐‐‐‐Timepoint: for the duration of the treatment period; INCLUSION CRITERIA: Key INCLUSION CRITERIA: 1.Males and females =>18yrs of age. 2.If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol. 3.An episode of acute diverticulitis that resolved without colonic resection. 4.Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted