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IleusPhase 3NCT00528970

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

A Phase 3 study testing MOA-728 in people with Ileus, run by Bausch Health Americas, Inc. at 106 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ileus
What is being tested?
MOA-728
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
106 sitesin 11 countries
Study dates
17 Oct 2007to 5 Feb 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

106 sites in 11 countries.

106 sites in 11 countries

United States75 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Ann Arbor, Michigan, 48109-5048

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Bellevue, Washington, 98005

  • Study site

    Bend, Oregon, 97701

  • Study site

    Benton, Arkansas, 72015

  • Study site

    Boston, Massachusetts, 02118

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Chapel Hill, North Carolina, 27599-7081

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Cleveland, Ohio, 44109

  • Study site

    Colton, California, 92324

  • Study site

    Columbia, Missouri, 65212

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Denver, Colorado, 80218

  • Study site

    Denver, Colorado, 80220

  • Study site

    Des Moines, Iowa, 50309

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Flint, Michigan, 48503

  • Study site

    Fort Worth, Texas, 76135

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Inverness, Florida, 34452

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Knoxville, Tennessee, 37934

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Loma Linda, California, 92354

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90033

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Memphis, Tennessee, 38103

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33156

  • Study site

    Milwaukee, Wisconsin, 53295

  • Study site

    Morgantown, West Virginia, 26506

  • Study site

    Naples, Florida, 34119

  • Study site

    Nashville, Tennessee, 37212

  • Study site

    New Brunswick, New Jersey, 08903

  • Study site

    New York, New York, 10016

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Omaha, Nebraska, 68124

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Orange, California, 92868

  • Study site

    Orlando, Florida, 32804

  • Study site

    Pensacola, Florida, 32504

  • Study site

    Peoria, Illinois, 61603

  • Study site

    Philadelphia, Pennsylvania, 19102

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19107-5092

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Pittsburgh, Pennsylvania, 15232

  • Study site

    Portland, Oregon, 97239

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Jose, California, 95124

  • Study site

    Santa Barbara, California, 93105

  • Study site

    Sellersville, Pennsylvania, 18960

  • Study site

    Sioux Falls, South Dakota, 57105

  • Study site

    Springfield, Massachusetts, 01199

  • Study site

    Stony Brook, New York, 11794-8480

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tampa, Florida, 33606

  • Study site

    Temple, Texas, 76508

  • Study site

    The Bronx, New York, 10467

  • Study site

    Winchester, Virginia, 22601

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winston-Salem, North Carolina, 27157

Other trials in United States

South Africa7 sites

  • Study site

    Durban Kwa-Zulu, KwaZulu-Natal, 3201

  • Study site

    Moreletapark Pretoria, 0044

  • Study site

    Pretoria

  • Study site

    Pretoria Gauteng, 0084

  • Study site

    Pretoria Gauteng, 0181

  • Study site

    Somerset West, Western Cape, 7130

  • Study site

    Worcester, Western Cape, 6850

Other trials in South Africa

Hungary4 sites

  • Study site

    Nyíregyháza, 4400

  • Study site

    Pécs, 7624

  • Study site

    Székesfehérvár, 8000

  • Study site

    Veszprém, 8200

Other trials in Hungary

Italy4 sites

  • Study site

    Bergamo, 24040

  • Study site

    Corso Giovecca 203, Ferrara, 44100

  • Study site

    Gemelli, Rome, 00168

  • Study site

    Padova, Via Giustiniani 2, 35100

Other trials in Italy

Canada3 sites

  • Study site

    Edmonton, Alberta, T6G 2G3

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Germany3 sites

  • Study site

    Augustenburger Platz 1, State of Berlin, 13353 DEU

  • Study site

    Heidelberg, 110 69120

  • Study site

    Nussbaumstrasse 20, Muenchen, 80336 DEU

Other trials in Germany

Poland3 sites

  • Study site

    Bydgoszcz, 85-094

  • Study site

    Polnocna 42, Łódź Voivodeship, 91 425

  • Study site

    Powstancow Wielkopolskich 72, Szczecin, 70-111

Other trials in Poland

Australia2 sites

  • Study site

    Adelaide SA, 5006

  • Study site

    Elizabeth Vale SA, 5112

Other trials in Australia

Belgium2 sites

  • Study site

    De Pintelaan 185, Gent Belgium, 9000

  • Study site

    Wilrijkstraat 10, Edegem, 2650

Other trials in Belgium

Netherlands2 sites

  • Study site

    Jan Toorpstraat 164, Amsterdam, 1061

  • Study site

    Roosendaal, 4708

Other trials in Netherlands

South Korea1 site

  • Kangnam-Gu

    Seoul, 135 710

Other trials in South Korea

About this study

Official title: 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.

Conditions
Ileus
Being tested
MOA-728, Placebo
Keywords
POI, Hernia, Ventral Wall Hernia Repair, Post Operative Ileus
Medical subject headings
Ileus, Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOA-728Drug

    Also called Methylnaltrexone

    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.

Study groups in NCT00528970
Study groupRoleWhat they receive
MOA-728 12 mgExperimentalParticipants 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.
Receives: Drug: MOA-728
MOA-728 24 mgExperimentalParticipants 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.
Receives: Drug: MOA-728
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Bowel Movement

    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.

    Measured: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

Secondary outcomes (3)

  1. Time to Discharge Eligibility

    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.

    Measured: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

  2. Time to Discharge Order Written From the End of Surgery

    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.

    Measured: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

  3. 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)

    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.

    Measured: Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2007 (estimated)
  2. Study start17 Oct 2007
  3. Primary completion5 Feb 2008
  4. Study completion5 Feb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00528970
Sponsor's protocol ID
3200L2-301
Status last verified
Aug 2019
First submitted
11 Sep 2007
Last updated
4 Sep 2019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MOA-728 in people with Ileus, run by Bausch Health Americas, Inc. at 106 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, South Africa, Hungary, Italy, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00528970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.

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