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Trial of Alvimopan in Major Spine Surgery

NCT02789111 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-12-01

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Alvimopan

Alviimopan 12 mg twice daily up to 15 doses

DRUG

Placebo

Placebo twice daily up to 15 doses

Sponsors & Collaborators

Principal Investigators

  • Bhiken Naik, MBBCh · Anesthesiology Attending

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2018-12-01
Completion
2018-12-01

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT02789111 on ClinicalTrials.gov