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

Ileus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528970
• Other study ID #: 3200L2-301
• Status: Completed
• Phase: Phase 3
• Start date: October 17, 2007
• Est. completion date: February 5, 2008

Study information

• Verified date: August 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 large (greater than or equal to [≥]10 centimeters) ventral hernias with or without a mesh prosthesis via laparotomy or laparoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: February 5, 2008
• Est. primary completion date: February 5, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ileus

Intervention

Drug:
• MOA-728
MOA-728 will be administered per the dose and schedule specified in the arm.
• Placebo
Placebo matching to MOA-728 will be administered per the schedule specified in the arm.

Locations

Country	Name	City	State
Korea, Republic of	Kangnam-Gu	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Progenics Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Secondary	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.	Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Secondary	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.	Day 2