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NCT00528970 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Ileus, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
374
Enrollment target
20
Study locations

NCT00528970: Completed Phase 3 study of Ileus, sponsored by Bausch Health Americas.

NCT00528970 is a Phase 3 study of Ileus that has completed, run by Bausch Health Americas. The registered enrollment target is 374 participants, roughly in line with the 410-participant average among 5 other Ileus trials with a reported enrollment target. The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00528970, a Phase 3 study of Ileus, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
374 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

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 readmitte

Conditions Studied

Ileus

Interventions

  • DRUG Placebo
  • DRUG MOA-728

Study Locations (20)

Florida

  • - Inverness
  • - Jacksonville
  • - Jacksonville
  • - Melbourne
  • - Miami
  • - Miami
  • - Naples
  • - Orlando
  • - Pensacola

California

  • - Colton
  • - Laguna Hills
  • - Loma Linda
  • - Long Beach
  • - Los Angeles
  • - Orange
  • - San Jose
  • - Santa Barbara

Colorado

  • - Denver
  • - Denver

Arkansas

  • - Benton

Trial Details

FieldValue
Enrollment Target 374 participants
Start Date 2007-10-17
Est. Completion 2008-02-05
Phase Phase 3
Bausch Health Americas

168 total trials

What the finished NCT00528970 record still lists

NCT00528970 is an interventional study that assigns participants to a tested intervention. The registered 374 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 410-participant average among 5 other Ileus trials with a reported enrollment target.

The record links to 1 condition, with Ileus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00528970 names 20 study sites across 4 states, led by Florida, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT00528970 about?

NCT00528970 is a clinical study titled "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 ha...

What is the current status of trial NCT00528970?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 374 participants. The study started on 2007-10-17. Estimated completion is 2008-02-05.

What conditions does trial NCT00528970 study?

This clinical trial studies the following conditions: Ileus.

What interventions are being tested in trial NCT00528970?

The interventions under investigation include: Placebo (DRUG), MOA-728 (DRUG).

Who is sponsoring clinical trial NCT00528970?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00528970 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT00528970, the US trial registry maintained by the National Library of Medicine. NCT00528970 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.