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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00528970
Recruitment Status : Completed
First Posted : September 14, 2007
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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.

Condition or disease Intervention/treatment Phase
Ileus Drug: MOA-728 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 17, 2007
Actual Primary Completion Date : February 5, 2008
Actual Study Completion Date : February 5, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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 Name: 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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528970


Locations
Show Show 106 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Progenics Pharmaceuticals, Inc.
Investigators
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Study Director: Lindsey Mathew Bausch Health Americas, Inc.
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00528970    
Other Study ID Numbers: 3200L2-301
First Posted: September 14, 2007    Key Record Dates
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019
Last Verified: August 2019
Keywords provided by Bausch Health Americas, Inc.:
POI
Hernia
Ventral Wall Hernia Repair
Post Operative Ileus
Additional relevant MeSH terms:
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Ileus
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia, Abdominal
Methylnaltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents