Status:
COMPLETED
Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Post-Operative Ileus (POI)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly sh...
Eligibility Criteria
Inclusion
- Male and female participants at least 18 years of age.
- All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Participants must sign an informed consent form (ICF).
- Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia.
- Females of childbearing potential must have a negative serum pregnancy test at the screening visit.
- Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.
Exclusion
- Participants who received any investigational new drug in the 30 days prior to screening visit.
- Females who are pregnant or lactating.
Key Trial Info
Start Date :
October 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2008
Estimated Enrollment :
524 Patients enrolled
Trial Details
Trial ID
NCT00401375
Start Date
October 31 2006
End Date
February 29 2008
Last Update
September 4 2019
Active Locations (1)
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1
Progenics Pharmaceuticals
Tarrytown, New York, United States, 10591