Phase 3 N=374 Randomized Quadruple-blind Treatment

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

Ileus

Bottom Line

View on ClinicalTrials.gov: NCT00528970 ↗

Enrolled (actual)

374

Serious AEs

17.4%

Results posted

Sep 2019

Primary outcome: Primary: Time to First Bowel Movement — 93.3; 100.4; 91.3 hours — p=0.944

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MOA-728 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch Health Americas, Inc.
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to First Bowel Movement	93.3; 100.4; 91.3	0.944
SECONDARY Time to Discharge Eligibility	44.9; 51.4; 41.4	—
SECONDARY Time to Discharge Order Written From the End of Surgery	130.6; 123.8; 132.9	—
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)	10; 19; 7	—

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.

Eligibility 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00528970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.