CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 274 enrolled
Drug / intervention
Alvimopam +1 moredrug
Likely dose
300 mg Polyethylenefrom 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/NCT01143259
NCT01143259N/ACompleted
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A Randomized, Double Blind, Placebo Controlled Study to Study Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use

Intermountain Health Care, Inc.·interventional·Posted Jun 14, 2010·Updated Sep 4, 2014

In Brief

A clinical study evaluating Alvimopam and 300 mg Polyethylene for Ileus. Completed, enrolled 274 participants across 9 sites.

Detailed Summary

The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIleus
CountriesUnited States
CollaboratorsCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2010
Enrollment StartMay 1, 2010
Primary CompletionJun 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.1 years ago

Interventions

Alvimopamdrug

The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.

300 mg Polyethylenedrug

The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.