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Completed

NCT Number: NCT00528970

A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Adelaide SA, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MOA-728

Drug

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

Other names: Methylnaltrexone

Placebo

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  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)

    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.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Collaborators

  • Progenics Pharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 14, 2007
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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