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 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT01050595
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older in the ICU
* Opioids for analgesia for at least 24 hours.
* Opioid-induced constipation with no bowel movement within the last 72 hours.
* Women of childbearing potential had negative pregnancy tests.
Exclusion Criteria:
* Contraindication to use of the GI tract
* Diarrhea on admission
* Bowel surgery within 8 weeks of admission
* Ileostomy or colostomy
* Not expected to live or stay more than 3 days in the intensive care unit
* Constipation that was not primarily caused by opioids (as determined by the investigator)
* No opioid use in the last 24 hours,
* Mechanical gastrointestinal obstruction
* An indwelling peritoneal catheter
* Clinically active diverticular disease
* Fecal impaction
* Acute surgical abdomen
* History of Crohn's disease or ulcerative colitis
* On Palliative care
* Less than 18 years old
* Bowel movement in last 72 hours.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01050595
Study Brief:
Protocol Section:
NCT01050595