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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT02550418
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent,
* Men or women aged 18 to 75 years,
* Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
* Established disease,
Exclusion Criteria:
* Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
* Toxic megacolon or fulminant colitis,
* Colon resection,
* Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
* Malabsorption syndromes,
* Celiac disease,
* Bleeding hemorrhoids,
* Active peptic ulcer disease
* Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
* Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
* Any severe infectious disease (e.g., tuberculosis, AIDS),
* Severe co-morbidity substantially reducing life expectancy,
* History of colorectal cancer,
* History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02550418
Study Brief:
Protocol Section:
NCT02550418