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

NCT00545740

Run by

Shire

People needed

590

Starts

2007-11-28

Expected to finish

2012-03-05

Last updated by the study team

2021-06-14

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

• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• GW Research — Chula Vista, California, United States
• Monterey Bay GI Research Institute, Inc — Monterey, California, United States
• Rancho Cucamonga C. Trials — Rancho Cucamonga, California, United States
• Clinical Trials Research — Roseville, California, United States
• Medical Associates Research — San Diego, California, United States
• Torrance Clinical Research — Torrance, California, United States
• Rocky Mountain Gastroenterology Associates — Thornton, Colorado, United States
• Gastroenterology Associates of Fairfield County — Bridgeport, Connecticut, United States
• Yale Center for Clinical Investigation — New Haven, Connecticut, United States
• ZASA Clinical Research — Boynton Beach, Florida, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Compass Research — Orlando, Florida, United States
• Accord Clinic Research, LLC — Port Orange, Florida, United States
• Florida Medical Clinic/Tampa Clinical Trials — Tampa, Florida, United States
• Gastroenterology Associates of Central Georgia, LLC — Macon, Georgia, United States
• Saint John's Research Institute — Anderson, Indiana, United States
• Digestive & Liver Disease Consultants — Clive, Iowa, United States
• New Orleans Research Institute — Metairie, Louisiana, United States
• Digestive Disease Associates — Baltimore, Maryland, United States
• Endoscopic Microsurgery Associates, PA — Towson, Maryland, United States
• Borgess Research Institute — Kalamazoo, Michigan, United States
• Dedicated Clinical Research — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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