CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 49 enrolled
Drug / intervention
Alvimopan +1 moredrug
Likely dose
Alvimopan 12 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02789111
NCT02789111Phase 4Completed
CompareCT.gov

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

University of Virginia·interventional·Posted Jun 2, 2016·Updated Dec 1, 2020

In Brief

A Phase 4 clinical trial evaluating Alvimopan and Placebo for Constipation. Completed, enrolled 49 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2, 2016
Enrollment StartJun 1, 2016
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.1 years ago

Interventions

Alvimopandrug

Alviimopan 12 mg twice daily up to 15 doses

Placebodrug

Placebo twice daily up to 15 doses