Prevention of Recurrence of Diverticulitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Diverticulitis

In brief

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

Key facts

Study ID

NCT00545103

Run by

Shire

People needed

592

Starts

2007-12-06

Expected to finish

2011-11-28

Last updated by the study team

2021-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Medical Affiliated Research Center, Inc — Huntsville, Alabama, United States
• Alabama Digestive Disorders Center, PC — Huntsville, Alabama, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Digestive and Liver Disease Specialists — Garden Grove, California, United States
• High Desert Gastroenterology, Inc. — Lancaster, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• CA Physicians Research Alliance — Oceanside, California, United States
• Digestive Care Medical Center — San Carlos, California, United States
• Rider Research Group — San Francisco, California, United States
• Huntington Medical Foundation — San Marino, California, United States
• Clinical Research of the Rockies — Lafayette, Colorado, United States
• Arapahoe Gastroenterology, PC — Littleton, Colorado, United States
• Litchfield County Gastroenterology Associates, LLC — Torrington, Connecticut, United States
• Madeleine DuPree, MD — Boynton Beach, Florida, United States
• Palmetto Research LLC — Hialeah, Florida, United States
• Mark Lamet, MD — Hollywood, Florida, United States
• Digestive Disease Consultants — Maitland, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• United Medical Research — New Smyrna Beach, Florida, United States
• West Wind'r Research & Development — Tampa, Florida, United States
• Atlanta Gastroenterology Associates — Marietta, Georgia, United States
• Birmingham Gastroenterology Associates, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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