Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

November 21, 2019 updated by: Bausch Health Americas, Inc.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus.

Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

495

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
      • Woodville South, South Australia, Australia, 5011
  • Former Serbia and Montenegro
      • Beograd, Former Serbia and Montenegro, 11000
  • Germany
      • Berlin, Germany, 13353
      • Halle, Germany, 06097
      • Heidelberg, Germany, 69120
      • Munchen, Germany, 80336
  • Hungary
      • Budapest, Hungary, 1125
      • Gyor, Hungary, 9024
      • Pecs, Hungary, 7624
      • Szekesfehervar, Hungary, 8000
  • Italy
      • Bologna, Italy, 40138
      • Ferrara, Italy, 44100
      • Genova, Italy, 16132
      • Monza, Italy, 20052
      • Padova, Italy, 35128
      • Roma, Italy, 00168
    • Zingonia
      • Osio Sotto, Zingonia, Italy, 24040
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 135-710
  • Poland
      • Katowice, Poland, 40-752
      • Krakow, Poland, 31-202
      • Lodz, Poland, 91-425
      • Poznan, Poland, 60-355
  • Romania
      • Bucharest, Romania, 020475
      • Bucharest, Romania, 014461
      • Bucharest, Romania, 042122
      • Bucharest, Romania, 050098
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0181
      • Pretoria, Gauteng, South Africa, 0084
    • Kwa-Zulu Natal
      • Pietermaritzburg, Kwa-Zulu Natal, South Africa, 3201
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7580
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
    • California
      • Chula Vista, California, United States, 92114
      • Colton, California, United States, 92324
      • Los Angeles, California, United States, 90033
      • Oceanside, California, United States, 92056
      • Palo Alto, California, United States, 94304
      • San Jose, California, United States, 95124
      • Torrance, California, United States, 90509
    • Colorado
      • Denver, Colorado, United States, 80262
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Florida
      • Bay Minette, Florida, United States, 36507
      • Jacksonville, Florida, United States, 322224
      • Melbourne, Florida, United States, 32901
      • Naples, Florida, United States, 34119
      • Saint Petersburg, Florida, United States, 33701
      • Vero Beach, Florida, United States, 32960
      • Weston, Florida, United States, 33331
    • Georgia
      • Atlanta, Georgia, United States, 30303
      • Atlanta, Georgia, United States, 30342
      • Marietta, Georgia, United States, 30060
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
      • Naperville, Illinois, United States, 60540
      • Park Ridge, Illinois, United States, 60068
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maryland
      • Hagerstown, Maryland, United States, 21740
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
    • Minnesota
      • Saint Paul, Minnesota, United States, 55104
      • Saint Paul, Minnesota, United States, 55114
    • New York
      • Albany, New York, United States, 12208
      • Kingston, New York, United States, 12401
      • New York, New York, United States, 10016
      • New York, New York, United States, 10029
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Ohio
      • Cleveland, Ohio, United States, 44109
      • Columbus, Ohio, United States, 43210
      • Zanesville, Ohio, United States, 43701
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Bend, Oregon, United States, 97701
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15213
      • Wilkes-Barre, Pennsylvania, United States, 18711
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
      • Providence, Rhode Island, United States, 02903
    • Tennessee
      • Memphis, Tennessee, United States, 38103
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Fort Worth, Texas, United States, 76104
      • Fort Worth, Texas, United States, 76107
      • San Antonio, Texas, United States, 78212
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Norfolk, Virginia, United States, 23507
      • Winchester, Virginia, United States, 22601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Must be scheduled for a segmental colectomy via open laparotomy with general anesthesia
  • Subjects with history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met
  • Subjects must meet the American Society of Anesthesiologists physical status I, II or III

Exclusion:

  • Subjects who are scheduled for laparoscopic surgery for the segmental colectomy
  • Subjects with a recent history (<1 year prior to randomization) of abdominal radiation therapy; Subjects with a history of small bowel obstruction, known or suspected bowel adhesions (other than minor, clinically nonsignificant adhesions)
  • Subjects undergoing operations resulting in gastrointestinal ostomies, or who require use of post operative nonsteroidal anti-inflammatory drugs (NSAIDs)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the MOA-728 regimen than with a placebo regimen.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Investigators

  • Study Director: Jeff Cohn, Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria

October 11, 2006

First Posted (Estimate)

October 13, 2006

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3200L2-300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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