Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients

• Status: Terminated
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Constipation is a known complication of the postoperative period after spinal surgery, where prescription pain medicines called opioids are traditionally used in high doses for the treatment of surgery-related pain. The goal of this study is to determine the effectiveness of Movantik (naloxegol)-a FDA-approved drug used to treat constipation that is caused by opioids-in preventing constipation in patients undergoing spinal fusion surgery at MGH.

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

Details

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

Criteria

Inclusion Criteria:

• Male or female patients between the ages of 18 and 75 years undergoing non-urgent, elective spinal fusion at Massachusetts General Hospital who are admitted to the neurosurgery floor from the operating room

Exclusion Criteria:

• Patients who are taken to the operating room from another inpatient floor or service (already hospitalized prior to surgery)

• Patients with evidence of bowel obstruction

• Patients unable to take oral medications by mouth or by enteric feeding tube (gastrostomy or jejunostomy)

• Patients with a documented or potential allergy or adverse reaction to Movantik (naloxegol) from outpatient use

• Patients currently taking Movantik (naloxegol) in the outpatient setting

• Patients with a preoperative diagnosis of irritable bowel syndrome (IBS) obtained via Rome III questionnaire on screening

• Patients with disruptions to the blood-brain barrier (eg, multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy)

• Patients with a history of cancer.

• Patients concomitantly using strong CYP3A4 inhibitors (eg, clarithromycin, ketoconazole), strong CYP3A4 inducers and other opioid antagonists.

• Patients with severe hepatic impairment.

• Patients with a previous history of or risk of bowel perforation.

• Patients with a post-op regional anesthetic technique employed like a continuous epidural or spinal.

• Patients for which local anesthetics will be placed in the wound.