Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients

NCT02946580 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-09-10

Study results available
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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.

Conditions

Interventions

DRUG

MOVANTIK™ (naloxegol)

DRUG

Sugar Pill

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Kyle Staller, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02946580 on ClinicalTrials.gov