Naloxegol to Prevent Lower Gastrointestinal Paralysis in Critically Ill Adults Administered Opioids

• Status: Terminated
• Trial end date: 2019-10-09
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the addition of naloxegol (Movantik) to a laxative protocol in critically ill adults requiring scheduled opioid (e.g. fentanyl) therapy. Half of the participants will receive naloxegol and a laxative protocol and half the participants will receive a placebo and a laxative protocol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Analgesics, Opioid; Bisacodyl; Bismuth subsalicylate; Citric Acid; Magnesium citrate; Methylnaltrexone; Naloxegol; Naltrexone; Polyethylene glycol 3350; Senna Extract; Sennoside A&B

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Admitted to an ICU

• Expected to require admission to an ICU for ≥ 48 hours

• Intravenous opioid administration in the prior 24 hours of ≥ 100 mcg fentanyl equivalents

Exclusion Criteria:

• Scheduled use of an opioid ≥ 10 mg morphine equivalents per day in the week prior to ICU admission

• History of constipation (≤ 2 SBM per week and current use of stool softener or laxative therapy) prior to ICU admission

• Current scheduled use of a medication affecting gastric motility

• Current use of a medication known to be a strong CYP3A4 inhibitor

• History of a neurologic condition that may affect the permeability of the blood-brain barrier

• Acute GI condition (e.g., clinical evidence of acute fecal impaction/complete obstruction, acute surgical abdomen, acute GI bleeding)

• Condition affecting GI motility or function (e.g. inflammatory bowel disease requiring immunosuppressive therapy, symptomatic Clostridium difficile, active diverticular disease, surgery on the colon or abdomen within 60 days of ICU admission)

• Current use of total parenteral nutrition

• Administration of enteral nutrition through a jejunal tube

• Severe hepatic dysfunction

• Endstage renal disease defined as either i. calculated creatinine clearance ≤ 10ml/min or ii. Any current use of renal replacement therapy

• Inability to enroll in study and initiate study medication within 48 hours of the patient begin first initiated on scheduled IV opioid therapy after ICU admission

• Unreliable method for enteral, gastric and/or oral medication administration (e.g., no feeding tube, nasogastric tube is on suction)

• Current or previous use of an opioid antagonist agent (e.g., naloxegol, methylnaltrexone) in the past 30 days

• Pregnant or actively lactating females

• Current participation in another interventional clinical study

• Inability to obtain informed consent