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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT04361656
Eligibility Criteria:
Inclusion Criteria:
* Is scheduled for colonoscopy evaluation during his hospitalization to one of the trial sites (SJPH, PPH, or SJMH).
* Has a negative urine pregnancy test (hCG) for female of reproductive age.
* Provide an Informed Consent / has a legally acceptable representative capable of understanding the Informed Consent document and providing consent on the participant's behalf.
* Provide a separate signed and dated Informed Consents for colonoscopy procedure and anaesthesia administration as per site policy.
Exclusion Criteria:
* Has a documented or suspected bowel obstruction (small bowel obstruction, volvulus, gastric outlet obstruction, ileus, or toxic megacolon).
* Has a documented gastroparesis.
* Has severe diarrhea (\>8 bowel movements per day).
* Has severe encephalopathy or obtunded (GCS \< 13).
* Has a documented or suspected acute coronary syndrome or recent myocardial infarction within 12 weeks prior to enrollment.
* Has renal impairment with GFR less than 30 ml/min/1.73 m2 on the day of enrollment (end-stage renal disease on renal replacement therapy can be enrolled).
* Has severe liver impairment with Child-Pugh class B or C.
* Has symptomatic heart failure (NYHA class III or IV) or prohibitive pre-procedure cardiac risk (documented by primary team or cardiology prior to enrollment).
* Has a known hypersensitivity to Lubiprostone or its class.
* Is pregnant or lactating.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04361656
Study Brief:
Protocol Section:
NCT04361656