Asacol Acute Diverticulitis(DIVA)Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Diverticulitis

In brief

The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.

Key facts

Study ID

NCT00554099

Run by

Warner Chilcott

People needed

117

Starts

2007-11-01

Expected to finish

2010-03-01

Last updated by the study team

2013-04-22

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of acute diverticulitis
• Female patients must be postmenopausal (at least 1 year without spontaneous menses) or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment]; 2-barrier methods [e.g., condom, diaphragm, or spermicide]; intrauterine device or verbal report of partner with history of non-reversed vasectomy)
• Willing and able to participate in the study and provide a signed informed consent

You may not qualify if…

• Presence of diverticular complications (e.g., fistula, abscess, obstruction, stenosis);
• Active or recent history (within 6 months) of a peptic ulcer;
• Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;
• History of major abdominal surgery (as determined by the Investigator);
• History of GI surgery within 3 months of diagnosis of acute diverticulitis;
• History of immunocompromising disease, human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS);
• If female patient, active or recent history of endometriosis or dysmenorrhea;
• Received a dose of a product that contains, or is metabolized to, mesalamine by any route within 4 weeks before the screening visit;

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Facility — Los Angeles, California, United States
• Research Site — Merced, California, United States
• Research Site — Oakland, California, United States
• Research Facility — Orange, California, United States
• Research Site — Palm Springs, California, United States
• Research Site — Pasadena, California, United States
• Research Site — Lafayette, Colorado, United States
• Research Site — Littleton, Colorado, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Jacksonsville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Facility — Zephyrhills, Florida, United States
• Research Site — Pratt, Kansas, United States
• Research Site — Monroe, Louisiana, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Chesterfield, Michigan, United States
• Research Site — Tupelo, Mississippi, United States
• Research Site — Mexico, Missouri, United States
• Research Facility — Cedar Knolls, New Jersey, United States
• Research Site — Great Neck, New York, United States
• Research Site — Lake Success, New York, United States
• Research Site — Setauket, New York, United States
• Research Site — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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