Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

Post Operative Bowel Dysfunction Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387309
• Other study ID #: 3200L2-300
• Status: Completed
• Phase: Phase 3
• Start date: December 2006
• Est. completion date: November 2007

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion:

• Must be scheduled for a segmental colectomy via open laparotomy with general anesthesia

• Subjects with history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met

• Subjects must meet the American Society of Anesthesiologists physical status I, II or III

Exclusion:

• Subjects who are scheduled for laparoscopic surgery for the segmental colectomy

• Subjects with a recent history (<1 year prior to randomization) of abdominal radiation therapy; Subjects with a history of small bowel obstruction, known or suspected bowel adhesions (other than minor, clinically nonsignificant adhesions)

• Subjects undergoing operations resulting in gastrointestinal ostomies, or who require use of post operative nonsteroidal anti-inflammatory drugs (NSAIDs)

Related Conditions & MeSH terms

• Intestinal Diseases
• Post Operative Bowel Dysfunction

Intervention

Drug:
• Methylnaltrexone (MOA-728)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Former Serbia and Montenegro,  Germany,  Hungary,  Italy,  Korea, Republic of,  Poland,  Romania,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 MOA-728 regimen than with a placebo regimen.