CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 374 enrolled
Drug / intervention
MOA-728 +1 moredrug
Likely dose
Not stated in 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/NCT00528970
NCT00528970Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus After Ventral Hernia Repair

Bausch Health Americas, Inc.·interventional·Posted Sep 14, 2007·Updated Sep 4, 2019

In Brief

A Phase 3 clinical trial evaluating MOA-728 and Placebo for Ileus. Completed, enrolled 374 participants across 106 sites in 11 countries.

Detailed Summary

This study will evaluate the safety and efficacy of two different dose regimens (12 milligrams \[mg\] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of bowel function in participants receiving opioid analgesia administered via patient-controlled anesthesia (PCA), and who had undergone repair of large (greater than or equal to \[≥\]10 centimeters) ventral hernias with or without a mesh prosthesis via laparotomy or laparoscopy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIleus
CountriesAustralia, Belgium, Canada, Germany, Hungary, Italy, Netherlands, Poland, South Africa, South Korea, United States
CollaboratorsProgenics Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2007
Enrollment StartOct 17, 2007
Primary CompletionFeb 5, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.8 years ago

Interventions

MOA-728drug

MOA-728 will be administered per the dose and schedule specified in the arm.

Placebodrug

Placebo matching to MOA-728 will be administered per the schedule specified in the arm.