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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00603733
Eligibility Criteria:
Inclusion Criteria for Active phase:
* Newly diagnosed or recurrent, mild to moderate Ulcerative Colitis patients.
* Extent of colonic involvement confirmed within the past 36 months
* UCDAI score of at least 3 but not greater than 8 and a score of at least 1 for endoscopy
* Screening tests to rule out any abnormalities in stool, heart or kidney.
* Male or non-pregnant females between 18 to 75 years.
* Women of childbearing potential to use efficacious contraception as judged by the investigator.
* Written informed consent given.
Inclusion Criteria for Maintenance phase:
* Newly recruited subjects with documented mild to moderate UC entering the Run-in Phase: in clinical remission for at least 1 month and for a maximum of 3 years, and receiving 5-ASA 1.4 to 2.5 g/day for maintenance of quiescent disease
* Subjects from Active Phase: meeting remission criteria after the 8-week active period
* Extent of colonic involvement confirmed within the past 36 months by colonoscopy
* In complete remission at entry into the Maintenance Phase, defined as i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings; and iv) a Physician's Global Assessment (PGA) score of 0 or 1
* Screening tests to rule out any abnormalities in stool, heart or kidney.
Exclusion Criteria:
* Use of 5-ASA products at a dose \>2.5g/day within 7 days prior to entry.
* Proctitis, short bowel syndrome, prior bowel surgery, severe UC, other forms of Inflammatory Bowel Disease
* Infectious diseases, parasites, bacterial pathogens
* Allergy to aspirin or salicylate
* Liver or kidney abnormalities
* Alcohol or drug abuse
* Pregnancy
* Cancer
* Bleeding disorders, ulcers, autoimmune diseases
* Mental disorders
* Participation in clinical trial in last 30 days
* Inability to fill in diary cards / comply with protocol requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00603733
Study Brief:
Protocol Section:
NCT00603733