Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Warner Chilcott
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
male or female between 18 and 75 years of age;
have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
currently demonstrating moderately active disease
You may not be if
Patients will be excluded from admission to the study if they have/are:
a history of allergy or hypersensitivity to salicylates or aminosalicylates;
a history of extensive small bowel resection (\>1/2 the length of the small intestine) causing short bowel syndrome;
current renal or hepatic disease;
participated in any drug or device clinical study within 30 days of entry;
currently enrolled in any other clinical study;
received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
received any other topical rectal therapy during the week prior to the Screening Visit;
received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
if female, positive pregnancy test, or lactating.
Clareo Health | Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
