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Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

NCT00387309 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2019-11-25

No results posted yet for this study

Summary

Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.

Conditions

  • Post Operative Bowel Dysfunction

Interventions

DRUG

Methylnaltrexone (MOA-728)

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeff Cohn · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Completion
2007-11-30

Countries

  • United States
  • Australia
  • Germany
  • Hungary
  • Italy
  • Poland
  • Romania
  • Serbia and Montenegro
  • South Africa
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00387309 on ClinicalTrials.gov