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A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair

NCT00528970 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2019-09-04

Study results available
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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.

Conditions

  • Ileus

Interventions

DRUG

MOA-728

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Progenics Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Lindsey Mathew · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-17
Primary Completion
2008-02-05
Completion
2008-02-05

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • South Africa
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT00528970 on ClinicalTrials.gov