Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Warner Chilcott
This study is designed to evaluate the safety and efficacy of Asacol® 2.4 g/day in generally healthy, adult patients who have had an attack of acute diverticulitis. The study will evaluate the safety and efficacy of a 12 week treatment with Asacol® followed a 9 month non-treatment observation period in approximately 180 patients with acute diverticulitis.
Age
35–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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;
