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

August 12, 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 After Ventral Hernia Repair

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
374

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Adelaide SA, Australia, 5006
      • Elizabeth Vale SA, Australia, 5112
  • Belgium
    • Edegem
      • Wilrijkstraat 10, Edegem, Belgium, 2650
    • Gent Belgium
      • De Pintelaan 185, Gent Belgium, Belgium, 9000
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G3
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
  • Germany
      • Heidelberg, Germany, 110 69120
    • Berlin
      • Augustenburger Platz 1, Berlin, Germany, 13353 DEU
    • Muenchen
      • Nussbaumstrasse 20, Muenchen, Germany, 80336 DEU
  • Hungary
      • Nyiregyhaza, Hungary, 4400
      • Pecs, Hungary, 7624
      • Szekesfehervar, Hungary, 8000
      • Veszprem, Hungary, 8200
  • Italy
      • Bergamo, Italy, 24040
    • Ferrara
      • Corso Giovecca 203, Ferrara, Italy, 44100
    • Rome
      • Gemelli, Rome, Italy, 00168
    • Via Giustiniani 2
      • Padova, Via Giustiniani 2, Italy, 35100
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135 710
        • Kangnam-Gu
  • Netherlands
      • Roosendaal, Netherlands, 4708
    • Amsterdam
      • Jan Toorpstraat 164, Amsterdam, Netherlands, 1061
  • Poland
      • Bydgoszcz, Poland, 85-094
    • Lodz
      • Polnocna 42, Lodz, Poland, 91 425
    • Szczecin
      • Powstancow Wielkopolskich 72, Szczecin, Poland, 70-111
  • South Africa
      • Moreletapark Pretoria, South Africa, 0044
      • Pretoria, South Africa
      • Pretoria Gauteng, South Africa, 0084
      • Pretoria Gauteng, South Africa, 0181
    • Natal
      • Durban Kwa-Zulu, Natal, South Africa, 3201
    • Western Cape
      • Somerset West, Western Cape, South Africa, 7130
      • Worcester, Western Cape, South Africa, 6850
  • United States
    • Arkansas
      • Benton, Arkansas, United States, 72015
    • California
      • Colton, California, United States, 92324
      • Laguna Hills, California, United States, 92653
      • Loma Linda, California, United States, 92354
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90033
      • Orange, California, United States, 92868
      • San Jose, California, United States, 95124
      • Santa Barbara, California, United States, 93105
    • Colorado
      • Denver, Colorado, United States, 80218
      • Denver, Colorado, United States, 80220
    • Florida
      • Inverness, Florida, United States, 34452
      • Jacksonville, Florida, United States, 32224
      • Jacksonville, Florida, United States, 32216
      • Melbourne, Florida, United States, 32901
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33156
      • Naples, Florida, United States, 34119
      • Orlando, Florida, United States, 32804
      • Pensacola, Florida, United States, 32504
      • Tampa, Florida, United States, 33606
    • Illinois
      • Peoria, Illinois, United States, 61603
    • Iowa
      • Des Moines, Iowa, United States, 50309
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02118
      • Springfield, Massachusetts, United States, 01199
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5048
      • Detroit, Michigan, United States, 48201
      • Flint, Michigan, United States, 48503
    • Mississippi
      • Jackson, Mississippi, United States, 39202
    • Missouri
      • Columbia, Missouri, United States, 65212
    • Nebraska
      • Omaha, Nebraska, United States, 68131
      • Omaha, Nebraska, United States, 68124
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Albany, New York, United States, 12208
      • Bronx, New York, United States, 10467
      • New York, New York, United States, 10016
      • Stony Brook, New York, United States, 11794-8480
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7081
      • Durham, North Carolina, United States, 27710
      • Winston-Salem, North Carolina, United States, 27103
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44109
      • Columbus, Ohio, United States, 43210
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Bend, Oregon, United States, 97701
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19102
      • Philadelphia, Pennsylvania, United States, 19107-5092
      • Pittsburgh, Pennsylvania, United States, 15232
      • Pittsburgh, Pennsylvania, United States, 15213
      • Sellersville, Pennsylvania, United States, 18960
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
      • Memphis, Tennessee, United States, 38103
      • Nashville, Tennessee, United States, 37212
    • Texas
      • Fort Worth, Texas, United States, 76135
      • San Antonio, Texas, United States, 78229
      • Temple, Texas, United States, 76508
    • Virginia
      • Norfolk, Virginia, United States, 23507
      • Winchester, Virginia, United States, 22601
    • Washington
      • Bellevue, Washington, United States, 98005
      • Tacoma, Washington, United States, 98405
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53295

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females, ages 18 and older.
  • Scheduled for ventral wall hernia repair with general anesthesia.
  • Meets the American Society of Anesthesiologists physical status I, II, or III.

Exclusion Criteria:

  • Received investigational drug or procedure within 30 days of randomization.
  • Women who are pregnant or lactating.
  • Calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate [GFR] formula) less than or equal to (</=) 50 milliliters/minute (mL/min).

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MOA-728 12 mg
Participants will receive methylnaltrexone (MOA-728) 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Drug: MOA-728
MOA-728 will be administered per the dose and schedule specified in the arm.
Other Names:
  • Methylnaltrexone
Experimental: MOA-728 24 mg
Participants will receive MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Drug: MOA-728
MOA-728 will be administered per the dose and schedule specified in the arm.
Other Names:
  • Methylnaltrexone
Placebo Comparator: Placebo
Participants will receive placebo matching to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Drug: Placebo
Placebo matching to MOA-728 will be administered per the schedule specified in the arm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to First Bowel Movement
Time Frame: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Discharge Eligibility
Time Frame: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as tolerance of oral intake of liquids greater than (>) 500 milliliters (mL) per 8 hours without nausea or retching/vomiting. Analysis was performed by Kaplan-Meier estimate.
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Time to Discharge Order Written From the End of Surgery
Time Frame: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
The investigator or designee recorded the time of the order. Participants re-admitted to the hospital with a diagnosis of POI within 7 days after discharge was considered treatment failures. Analysis was performed by Kaplan-Meier estimate.
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at Day 2 (24 Hours) as Evaluated by the Opioid-Related Symptom Distress Scale (SDS)
Time Frame: Day 2
CMEs were defined using opioid-related SDS (assessed participant-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe (3) or very severe (4), with the exception of confusion. A total CME score was calculated by summing the number of CMEs across symptoms and ranged from 0 to 9. CME was counted for either nausea or vomiting/retching, or both and reported in this outcome measure.
Day 2

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch Health Americas, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Progenics Pharmaceuticals, Inc.

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3200L2-301

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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