Status:
COMPLETED
Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention
Lead Sponsor:
Ohio State University
Conditions:
Postoperative Ileus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized controlled trial will prospectively evaluate the clinical benefit for subcutaneous methylnaltrexone (MNTX) in counteracting the obstipatory (causing constipation) effects of spinal sur...
Detailed Description
Postoperative Ileus refers to the transient interruption of propulsive motor activity of the gastrointestinal (GI) tract that prevents effective movement of its contents and tolerance of oral intake. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03852524
Start Date
February 21 2019
End Date
May 12 2021
Last Update
October 27 2021
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210