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AzTrials

Post Operative Bowel DysfunctionPhase 3NCT00387309

Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

A Phase 3 study testing Methylnaltrexone (MOA-728) in people with Post Operative Bowel Dysfunction, run by Bausch Health Americas, Inc. at 92 sites in 10 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Operative Bowel Dysfunction
What is being tested?
Methylnaltrexone (MOA-728)
How many people
495 participants
Where
92 sitesin 10 countries
Study dates
Dec 2006to Nov 2007
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • 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)

Trial locations and contacts

92 sites in 10 countries.

92 sites in 10 countries

United States59 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Atlanta, Georgia, 30303

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Bay Minette, Florida, 36507

  • Study site

    Bend, Oregon, 97701

  • Study site

    Boston, Massachusetts, 02135

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chula Vista, California, 92114

  • Study site

    Cleveland, Ohio, 44109

  • Study site

    Colton, California, 92324

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Danville, Pennsylvania, 17822

  • Study site

    Denver, Colorado, 80262

  • Study site

    Fort Smith, Arkansas, 72901

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Hagerstown, Maryland, 21740

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Jacksonville, Florida, 322224

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kingston, New York, 12401

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Los Angeles, California, 90033

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Memphis, Tennessee, 38103

  • Study site

    Mobile, Alabama, 36617

  • Study site

    Naperville, Illinois, 60540

  • Study site

    Naples, Florida, 34119

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10029

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Oceanside, California, 92056

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Palo Alto, California, 94304

  • Study site

    Park Ridge, Illinois, 60068

  • Study site

    Pawtucket, Rhode Island, 02860

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Portland, Oregon, 97239

  • Study site

    Providence, Rhode Island, 02903

  • Study site

    Saint Paul, Minnesota, 55104

  • Study site

    Saint Paul, Minnesota, 55114

  • Study site

    San Antonio, Texas, 78212

  • Study site

    San Jose, California, 95124

  • Study site

    St. Petersburg, Florida, 33701

  • Study site

    Syracuse, New York, 13210

  • Study site

    Torrance, California, 90509

  • Study site

    Vero Beach, Florida, 32960

  • Study site

    Washington D.C., District of Columbia, 20007

  • Study site

    Weston, Florida, 33331

  • Study site

    Wilkes-Barre, Pennsylvania, 18711

  • Study site

    Winchester, Virginia, 22601

  • Study site

    Zanesville, Ohio, 43701

Other trials in United States

Italy7 sites

  • Study site

    Bologna, 40138

  • Study site

    Ferrara, 44100

  • Study site

    Genova, 16132

  • Study site

    Monza, 20052

  • Study site

    Osio Sotto, Zingonia, 24040

  • Study site

    Padova, 35128

  • Study site

    Roma, 00168

Other trials in Italy

Germany4 sites

  • Study site

    Berlin, 13353

  • Study site

    Halle, 06097

  • Study site

    Heidelberg, 69120

  • Study site

    München, 80336

Other trials in Germany

Hungary4 sites

  • Study site

    Budapest, 1125

  • Study site

    Győr, 9024

  • Study site

    Pécs, 7624

  • Study site

    Székesfehérvár, 8000

Other trials in Hungary

Poland4 sites

  • Study site

    Katowice, 40-752

  • Study site

    Krakow, 31-202

  • Study site

    Lodz, 91-425

  • Study site

    Poznan, 60-355

Other trials in Poland

Romania4 sites

  • Study site

    Bucharest, 014461

  • Study site

    Bucharest, 020475

  • Study site

    Bucharest, 042122

  • Study site

    Bucharest, 050098

Other trials in Romania

South Africa4 sites

  • Study site

    Cape Town, Western Cape, 7580

  • Study site

    Pietermaritzburg, KwaZulu-Natal, 3201

  • Study site

    Pretoria, Gauteng, 0084

  • Study site

    Pretoria, Gauteng, 0181

Other trials in South Africa

Australia3 sites

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Elizabeth Vale, South Australia, 5112

  • Study site

    Woodville South, South Australia, 5011

Other trials in Australia

South Korea2 sites

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 138-736

Other trials in South Korea

Serbia and Montenegro1 site

  • Study site

    Beograd, 11000

Other trials in Serbia and Montenegro

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.

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.

Being tested
Methylnaltrexone (MOA-728)
Keywords
Bowel

What participants receive

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

  • Methylnaltrexone (MOA-728)Drug

What is being measured

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

  1. 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.

Timeline

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

  1. First posted13 Oct 2006 (estimated)
  2. Study startDec 2006
  3. Study completionNov 2007

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
Double blind
Enrolment
495 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00387309
Sponsor's protocol ID
3200L2-300
Status last verified
Nov 2019
First submitted
11 Oct 2006
Last updated
25 Nov 2019
Results posted
No

Publications

  • Yu CS, Chun HK, Stambler N, Carpenito J, Schulman S, Tzanis E, Randazzo B. Safety and efficacy of methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2011 May;54(5):570-8. doi: 10.1007/DCR.0b013e3182092bde.

    PubMed 21471758

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methylnaltrexone (MOA-728) in people with Post Operative Bowel Dysfunction, run by Bausch Health Americas, Inc. at 92 sites in 10 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Italy, Germany, Hungary, Poland and 5 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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.. 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 NCT00387309, which also lists 1 linked publication.

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 25 Nov 2019.

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