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:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT00708656
Eligibility Criteria:
Inclusion Criteria:
Patients who meet the following criteria will be eligible for study entry:
* Male and female patients aged over 18 with ulcerative colitis confirmed by histology who are in remission (no symptoms of active disease, and modified Baron sigmoidoscopic score of 0 or 1)
* If female, must be (as documented in patient notes):
* postmenopausal (at least 1 year without spontaneous menses), or
* surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrollment), or
* using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrollment, or
* have a sexual partner with non-reversed vasectomy (with confirmed azoospermia), or
* be using 1 barrier method (e.g., condom, diaphragm, spermicide, or intra-uterine device)
* Patients whose ulcerative colitis has been in clinical remission for 4 weeks or longer, and who have had a symptomatic relapse within the past two years
* Patients taking mesalazine, sulfasalazine or other drug containing 5-ASA for 4 weeks or longer
* Patients capable of giving written informed consent
Exclusion Criteria:
The following patients will be excluded from the study:
* Patients with Crohn's disease
* Patients with symptoms of active colitis
* Modified Baron sigmoidoscopy score of 2 or 3
* Patients who have used oral, enema, intravenous or suppository preparations of corticosteroids, oral or intravenous ciclosporin, mesalazine enemas or suppositories within the past four weeks
* Patients taking azathioprine or 6-mercaptopurine who have altered the dose or started treatment within the past three months, (these drugs permitted in stable dose during the study)
* Patients with intolerance to Asacol 400 mg or mesalazine
* Women who are pregnant or lactating
* Patients with known HIV infection
* Patients with hepatic disease
* Patients with renal impairment (creatinine above local reference range), or with positive urine dipstick test to blood or protein
* Other serious medical or psychiatric illness that in the opinion of the investigator would possibly comprise the study
* Patients with problem alcohol excess or drug abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00708656
Study Brief:
Protocol Section:
NCT00708656