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

NCT00528970 | Completed Phase 3 Results

• 1 other identifier: 3200L2-301
• Study Type: interventional
• Target: 374
• Locations: 11 countries
• Sites: 106

Brief 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

Keywords

POI; Hernia; Ventral Wall Hernia Repair; Post Operative Ileus

Outcome Measures

Primary Outcomes (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.

  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)

• Time to Discharge Eligibility

  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

  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)

  Day 2

Study Arms (3)

MOA-728 12 mg

EXPERIMENTAL

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 24 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

MOA-728 DRUG

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

Also known as: Methylnaltrexone

MOA-728 12 mg; MOA-728 24 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (106)

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Benton, Arkansas, 72015, United States

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Colton, California, 92324, United States

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Laguna Hills, California, 92653, United States

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Loma Linda, California, 92354, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90033, United States

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Orange, California, 92868, United States

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San Jose, California, 95124, United States

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Santa Barbara, California, 93105, United States

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Denver, Colorado, 80218, United States

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Denver, Colorado, 80220, United States

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Inverness, Florida, 34452, United States

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Jacksonville, Florida, 32216, United States

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Jacksonville, Florida, 32224, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33156, United States

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Naples, Florida, 34119, United States

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Orlando, Florida, 32804, United States

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Pensacola, Florida, 32504, United States

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Tampa, Florida, 33606, United States

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Peoria, Illinois, 61603, United States

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Des Moines, Iowa, 50309, United States

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Kansas City, Kansas, 66160, United States

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Lexington, Kentucky, 40536, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02118, United States

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Boston, Massachusetts, 02215, United States

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Springfield, Massachusetts, 01199, United States

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Ann Arbor, Michigan, 48109-5048, United States

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Detroit, Michigan, 48201, United States

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Flint, Michigan, 48503, United States

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Jackson, Mississippi, 39202, United States

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Columbia, Missouri, 65212, United States

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Omaha, Nebraska, 68124, United States

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Omaha, Nebraska, 68131, United States

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New Brunswick, New Jersey, 08903, United States

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Albuquerque, New Mexico, 87106, United States

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Albany, New York, 12208, United States

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New York, New York, 10016, United States

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Stony Brook, New York, 11794-8480, United States

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Syracuse, New York, 13210, United States

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The Bronx, New York, 10467, United States

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Chapel Hill, North Carolina, 27599-7081, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27103, United States

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Winston-Salem, North Carolina, 27157, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44109, United States

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Columbus, Ohio, 43210, United States

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Oklahoma City, Oklahoma, 73104, United States

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Bend, Oregon, 97701, United States

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Portland, Oregon, 97239, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19102, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107-5092, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Sellersville, Pennsylvania, 18960, United States

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Providence, Rhode Island, 02906, United States

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Sioux Falls, South Dakota, 57105, United States

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Knoxville, Tennessee, 37934, United States

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Memphis, Tennessee, 38103, United States

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Nashville, Tennessee, 37212, United States

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Fort Worth, Texas, 76135, United States

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San Antonio, Texas, 78229, United States

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Temple, Texas, 76508, United States

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Norfolk, Virginia, 23507, United States

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Winchester, Virginia, 22601, United States

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Bellevue, Washington, 98005, United States

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Tacoma, Washington, 98405, United States

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Morgantown, West Virginia, 26506, United States

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Milwaukee, Wisconsin, 53295, United States

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Adelaide SA, 5006, Australia

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Elizabeth Vale SA, 5112, Australia

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Wilrijkstraat 10, Edegem, 2650, Belgium

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De Pintelaan 185, Gent Belgium, 9000, Belgium

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Edmonton, Alberta, T6G 2G3, Canada

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Vancouver, British Columbia, V6Z 1Y6, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Nussbaumstrasse 20, Muenchen, 80336 DEU, Germany

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Augustenburger Platz 1, State of Berlin, 13353 DEU, Germany

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Heidelberg, 110 69120, Germany

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Nyíregyháza, 4400, Hungary

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Pécs, 7624, Hungary

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Székesfehérvár, 8000, Hungary

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Veszprém, 8200, Hungary

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Corso Giovecca 203, Ferrara, 44100, Italy

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Gemelli, Rome, 00168, Italy

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Padua, Via Giustiniani 2, 35100, Italy

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Bergamo, 24040, Italy

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Jan Toorpstraat 164, Amsterdam, 1061, Netherlands

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Roosendaal, 4708, Netherlands

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Powstancow Wielkopolskich 72, Szczecin, 70-111, Poland

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Bydgoszcz, 85-094, Poland

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Polnocna 42, Łódź Voivodeship, 91 425, Poland

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Durban Kwa-Zulu, KwaZulu-Natal, 3201, South Africa

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Somerset West, Western Cape, 7130, South Africa

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Worcester, Western Cape, 6850, South Africa

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Moreletapark Pretoria, 0044, South Africa

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Pretoria, South Africa

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Pretoria Gauteng, 0084, South Africa

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Pretoria Gauteng, 0181, South Africa

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Kangnam-Gu

Seoul, 135 710, South Korea

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MeSH Terms

Conditions

Ileus; Hernia

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc

Lindsey.Mathew@bauschhealth.com

Study Officials

• Lindsey Mathew

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 14, 2007
• Study Start: October 17, 2007
• Primary Completion: February 5, 2008
• Study Completion: February 5, 2008
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Locations

BE (2); AU (2); DE (3); KR (1); US (75); HU (4); IT (4); NL (2); PL (3); ZA (7); CA (3)