Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients

Stopped early · Phase 4

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT02946580

Run by

Massachusetts General Hospital

People needed

53

Starts

2017-01-01

Expected to finish

2018-02-01

Last updated by the study team

2019-09-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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