Trial of Alvimopan in Major Spine Surgery

November 30, 2020 updated by: Bhiken I. Naik, MD, University of Virginia

Randomized, Double-Blind, Placebo-Controlled Trial of Alvimopan in Major Spine Surgery

The Investigator has chosen to study the reconstructive spinal surgery patient population because it is believed that the use of alvimopan in these patients at the University of Virginia will give the scientific community significant insight into the broader applicability of this drug into other surgical populations, the impact of this drug on the perception of pain (as opposed to simply the consumption of opioids), and its impact on total hospital charges, resource utilization, and functional outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pain control following major spine surgery is difficult to achieve. Opiates are often necessary in high doses, and may be associated with significant side effects. Such side effects may include urinary retention, altered mental status, depressed respiratory drive, and constipation, and may lead to reduced nutritional intake in the postoperative period. Importantly, post-operative nutrition may impact the incidence of complications following spine surgery.1 Alvimopan is a peripheral-acting opiate antagonist designed to decrease the gastrointestinal complications of perioperative systemic opioid administration.

Pain control following major spine surgery is difficult to achieve. Opiates are often necessary in high doses, and may be associated with significant side effects including constipation. Alvimopan is a drug approved by the Food and Drug Administration (FDA) and is used to help the bowel recover more quickly in patients who are having bowel surgery, so that they can eat solid foods and have regular bowel movements. Alvimopan is in a class of medications called peripherally acting mu-opioid receptor antagonists. It works by protecting the bowel from the constipation effects of opioid (narcotic) medications that are used to treat pain after surgery.

The purpose of this study is to determine if the use of alvimopan in major spine surgery reduces the time to first bowel movement. By assessing the use of alvimopan in reconstructive spinal surgery patients, researchers hope to give the scientific community insight into the broader use of this drug in other surgical populations, as well as gathering information on the impact of hospital charges and overall post-operative patient satisfaction.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major spine surgery scheduled as part of clinical care
  • 18-80 years

Exclusion Criteria:

  • More than three doses of any opioid within one week of surgery
  • Pregnancy
  • Prisoners
  • Unable to provide consent
  • Emergency surgery
  • Chronic kidney disease stage 5 (GFR < 15 ml/min)
  • Severe hepatic impairment
  • Recent myocardial infarction (within the last 3 months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Alvimopan
12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.
Drug: Alvimopan
Alviimopan 12 mg twice daily up to 15 doses
Other Names:
  • Entereg
PLACEBO_COMPARATOR: Placebo
Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.
Drug: Placebo
Placebo twice daily up to 15 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Bowel Movement
Time Frame: Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement
time to first bowel movement after surgery
Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Resumption of PO Intake
Time Frame: time to event ( up to 7 days); From date of day of surgery until the date of first documented PO intake
time to resumption oral intake after surgery
time to event ( up to 7 days); From date of day of surgery until the date of first documented PO intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Bhiken Naik, MBBCh, Anesthesiology Attending

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (ESTIMATE)

June 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18781

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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