Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT00194818
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide consent
* Age older than 18 years and younger than 80 years
* Confirmed diagnosis of ulcerative colitis by endoscopic or radiologic evaluation at least 4 weeks prior to randomization
* Active ulcerative colitis at time of screening (UCAI \> 4 \<12)
* Receiving stable doses of medications at least 4 weeks prior to receiving the first dose of study drug
* Agree to use of an adequate form of contraception throughout the study period for sexually active males and females of child-bearing potential
* Able to comply with protocol requirements
* Subjects may not be on any form of corticosteroids, immunosuppressives or anti-tumor necrosis factor (TNF) therapy
Exclusion Criteria:
* Critically ill
* Risk factors for toxicity to Asacol, including pre-existing hepatic disease (biopsy-proven cirrhosis, chronic active hepatitis, or serum aspartate aminotransferase, bilirubin, or alkaline phosphatase concentrations at least twice the upper limit of normal except for patients with the diagnosis of primary sclerosing cholangitis, a liver disease which occurs in patients with ulcerative colitis), renal dysfunction (serum creatinine concentration greater than 1.7 mg per deciliter \[150mmol per liter\]). Patients with primary sclerosing cholangitis (PSC), a liver disease that is often associated with ulcerative colitis, will be allowed to participate in the study if their liver function tests have been stable for at least 4 weeks. Previous studies have not shown any detrimental effects of Asacol on PSC.
* Systemic infections
* Pregnancy or a desire to become pregnant
* High alcohol consumption (more than seven drinks per week)
* Known hypersensitivity to Asacol
* Estimated survival of less than one year
* Unwilling to comply with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00194818
Study Brief:
Protocol Section:
NCT00194818