Phase 3
Completed N=374
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
Ileus
Source: ClinicalTrials.gov NCT00528970 ↗
Enrolled (actual)
374
Serious AEs
17.4%
Results posted
Sep 2019
Primary outcomePrimary: Time to First Bowel Movement — 93.3; 100.4; 91.3 hours — p=0.944
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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).
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. Informational only — not medical advice.