The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit

• Status: Withdrawn
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Naloxegol has recently been approved by the US Food and Drug Administration to treat opioid induced constipation in non-cancer chronic pain patients. Its effectiveness in acute care patients, however, is not known. Therefore, the researchers' goal is to investigate whether naloxegol is superior to osmotic laxatives for refractory constipation in ICU patients already receiving prophylactic stool softeners and simulant laxatives through a double-blind, randomized control trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: AstraZeneca
• Treatments: Naloxegol

Criteria

Inclusion Criteria:

1. Age ≥18 years

2. Admitted to an ICU at Massachusetts General Hospital (MGH)

3. Received ≥72 hours of continuous opioid infusion

4. Anticipated to require ≥48 hours of additional care in the ICU

5. Did not have a bowel movement in ≥72 hours

6. Allowed to receive (and tolerating) medications via nasogastric, orogastric, gastric, gastrojejunal, or oral route

7. Receiving at least trophic (10 mL/hr) of enteral nutrition

Exclusion Criteria:

1. Unable to provide informed consent or unavailable healthcare proxy

2. Not expected to survive >48 hours from time of enrollment

3. "Comfort measures only" status (i.e. palliative care)

4. Received medication other that docusate and senna glycoside for laxation

5. Had abdominal surgery that is expected to cause significant ileus

6. Mechanical bowel obstruction

7. Total bowel rest/exclusively receiving total parenteral nutrition

8. History of chronic constipation unrelated to opioid use

9. Compromised blood-brain-barrier

10. Current diagnosis of solid organ or hematologic cancer

11. On moderate/strong CYP3A4 inhibitors or strong CYP3A4 inducers

12. On other opioid antagonists

13. Pregnant or lactating females