Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention

• Status: Completed
• Trial end date: 2021-05-12
• Target enrollment: 0
• Participant gender: All

Summary

This randomized controlled trial will prospectively evaluate the clinical benefit for subcutaneous methylnaltrexone (MNTX) in counteracting the obstipatory (causing constipation) effects of spinal surgery without increasing narcotic usage or otherwise disrupting the recovery course of patients. Using a double-blind randomized design, either subcutaneous MNTX (0.15 mg/kg rounded to 8 mg or 12 mg) or placebo will be administered starting before surgery and then daily for three days. Information will be collected from medical records in IHIS up to 30 days prior to surgery and then for up to 30 days after surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Methylnaltrexone; Naltrexone

Criteria

Inclusion Criteria:

• Subject is scheduled to undergo a 1 - 3 level lumbar spinal fusion for degenerative spinal conditions including neurogenic claudication and/or lumbar radiculopathy with stenosis and/or spondylolisthesis.

• Subject must be over the age of 18 years old.

• Subject has been unresponsive to conservative care for a minimum of 6 months.

• The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol and have the ability to understand and give written informed consent.

Exclusion Criteria:

• Previous Treatment with MNTX

• History of mechanical gastrointestinal obstruction

• History of OIC refractory to outpatient medical management

• Presence of a peritoneal catheter for intraperitoneal chemotherapy or dialysis

• Clinically relevant active diverticular disease

• Recent history of bowel surgery within previous 12 months

• Use of vinca alkaloids within previous four months

• Renal failure defined as Estimated Glomerular Filtration Rate (eGFR) <30 ml/min per 1.73 m^2 or requires dialysis

• Known or suspected allergy to MNTX or similar compounds (e.g. naltrexone or naloxone)

• Participation in a study with investigational products within 30 days before first dose of MNTX

• Pregnant or nursing

• Clinically important abnormalities that may interfere with participation or compliance to the study, as determined by investigator.