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

Phase 3

• Registration Number: CTRI/2009/091/000450
• Lead Sponsor: Shire Pharmaceutical Development Ltd.Hampshire International Business ParkChineham, BasingstokeHampshire, RG24 8EPTelephone: +44 1256 894000 Fax: +44 1256 894707

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 584

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

Exclusion Criteria

Key Exclusion Criteria:
1.Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
2.Active peptic ulcer disease
3.History of or current presence of inflammatory bowel disease (IBD)
4.Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
5.Allergy or hypersensitivity to aspirin or related compounds
6.Allergy to radiologic contrast agents
7.Use of another Investigational product within 30 days of Baseline
8.Use of antibiotic therapy within 4 weeks of Baseline
9.Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well as drugs active at the 5HT-receptor or anti-spasmodic agents
10.Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable
11.Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
12.History of alcohol or other substance abuse within the previous year
13.Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
14.Females who are lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to recurrence of diverticulitisTimepoint: 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<br>

Secondary Outcome Measures

Name	Time	Method
1.To compare the proportion of subjects without recurrence of diverticulitisTimepoint: 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<br>;2.To compare the proportion of subjects with recurrence of complicated versus<br>uncomplicated diverticulitisTimepoint: between each of 3 doses of SPD476 (1.2g/day QD,2.4g/day QD, and 4.8g/day QD) and placebo QD<br>;3.To compare the proportion of subjects requiring surgical intervention for diverticular diseaseTimepoint: between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD<br>;4. To compare QoL using the EQ5D and HUI2 questionnaires between treatment groupsTimepoint: 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<br>;5. To assess the safety and tolerability of SPD476 1.2g/day QD, 2.4g/day QD, and 4.8g/day QDTimepoint: for the duration of the treatment period<br>