Prevention of Recurrence of Diverticulitis (PREVENT1)

Shire

Status and phase: Completed; Phase 3

Conditions: Diverticulitis

Treatments: Drug: Placebo; Drug: SPD476 (2.4 g); Drug: SPD476 (1.2g); Drug: SPD476 (4.8 g)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545740

2007-004895-37 (EudraCT Number)

SPD476-313

Details and patient eligibility

About

The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.

Enrollment: 590 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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590 participants in 4 patient groups, including a placebo group

SPD476 (1.2 g)

Experimental group

Treatment:

Drug: SPD476 (1.2g)

SPD476 (2.4 g)

Experimental group

Treatment:

Drug: SPD476 (2.4 g)

SPD476 (4.8 g)

Experimental group

Treatment:

Drug: SPD476 (4.8 g)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo