Asacol Acute Diverticulitis(DIVA)Study

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Mesalamine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;