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Therapeutic Areas: Gastroenterology
Disease Category: Gastrointestinal Diseases and Disorders

Trial Information

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

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.

Inclusion Criteria:

• Males and females =>18yrs of age.
• 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
• An episode of acute diverticulitis that resolved without colonic resection.
• Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted

Exclusion Criteria:

• Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
• Active peptic ulcer disease
• History of or current presence of inflammatory bowel disease (IBD)
• Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
• Allergy or hypersensitivity to aspirin or related compounds
• Allergy to radiologic contrast agents
• Use of another Investigational product within 30 days of Baseline
• Use of antibiotic therapy within 4 weeks of Baseline
• 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
• Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable
• Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
• History of alcohol or other substance abuse within the previous year
• Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
• Females who are lactating

Tracy Critchfield, MSM, Marketing/Recruitment Specialist
Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr., Suite 700
San Antonio, TX 78229
Phone: 210.949.0122
Fax: 210.949.0181

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