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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02202967
Eligibility Criteria:
INCLUSION CRITERIA:
Obscure occult gastrointestinal bleeding: presence of one or more of the following:
* Positive fecal occult blood test within last 3 months
* Iron deficiency anemia (ferritin \<100 ug/l, hemoglobin \[Hb\] 7-12 g/dl \[female\] or 7-13 g/dl \[male\])
* Drop in haemoglobin, \> 2gm/dl from baseline, in the absence of potential or actively bleeding lesion detectable on upper endoscopy or colonoscopy.
Normal/ absence of potentially bleeding lesions on full upper endoscopy and colonoscopy.
Taking low-dose aspirin (75-325m/ day) and/ or NSAIDs
MAIN EXCLUSION CRITERIA:
* Incomplete upper endoscopy or colonoscopy
* Systemic disease that is unstable at the time of randomisation (unstable vital signs; ongoing non-gastrointestinal investigations; frequent modifications to treatment)
* Intake of certain drugs: high-dose steroids (\>7.5-mg prednisolone/ day), cytotoxic drugs, or warfarin.
* Upper gastrointestinal lesions: oesophageal varices; oesophageal stricture; oesophageal or gastric neoplasms; pyloric stenosis; peptic ulcers; vascular malformations.
* Colonic disorders: neoplasms or adenomatous polyps; inflammatory bowel disease; vascular malformations; actively bleeding diverticular disease
* Women planning pregnancy, pregnant or women of child-bearing potential not using two contraceptive methods, one of which must be highly effective \[implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner\]
* Hypotension: systolic blood pressure \<100-mm Hg.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02202967
Study Brief:
Protocol Section:
NCT02202967