Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention

NCT03852524 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2018H0260
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Postoperative Ileus

Keywords

Spinal Arthrodesis; Ileus; Postoperative Ileus; Adult Spinal Deformity

Outcome Measures

Primary Outcomes (1)

• Time to First Bowel Movement

  The time it takes for the participant to have a bowel movement from the end of surgery.

  30 days post-operative

Secondary Outcomes (2)

• Time to Discharge

  30 Days post-operative

• Time to Discharge

  30 Days post-operative

Other Outcomes (1)

• Daily Narcotics

  30 days post-operative

Study Arms (2)

Study Arm

EXPERIMENTAL

The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).

Drug: Methylnaltrexone

Placebo Arm

PLACEBO COMPARATOR

The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).

Other: Placebo

Interventions

Methylnaltrexone DRUG

Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.

Study Arm

Placebo OTHER

Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Gifford CS, McGahan BG, Miracle SD, Minnema AJ, Murphy CV, Vazquez DE, Weaver TE, Farhadi HF. Design and feasibility of a double-blind, randomized trial of peri-operative methylnaltrexone for postoperative ileus prevention after adult spinal arthrodesis. Contemp Clin Trials. 2022 Jan;112:106623. doi: 10.1016/j.cct.2021.106623. Epub 2021 Nov 17.

  PMID: 34798295 DERIVED

MeSH Terms

Conditions

Ileus

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Shelby Miracle
• Organization: Ohio State University

shelby.miracle@osumc.edu

614-366-1648

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized in a 1:1 fashion to receive methylnaltrexone or placebo. Participants will remain in the group they are randomized to for the duration of the study.

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 25, 2019
• Study Start: February 21, 2019
• Primary Completion: April 4, 2021
• Study Completion: May 12, 2021
• Last Updated: October 27, 2021
• Results First Posted: October 6, 2021

Record last verified: 2021-10

Locations

US (1)