Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

Postoperative Ileus Clinical Trial

Official title:

A Phase II Double-Blind Randomized Parallel Group Study of Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367548
• Other study ID #: MNTX 203
• Status: Completed
• Phase: Phase 2
• Start date: July 2003
• Est. completion date: December 2004

Study information

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

Clinical Trial Summary

A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and females, 18 yrs or older

2. Patients who have undergone a segmental colectomy

3. Must be receiving opioids via IV.

Exclusion Criteria:

1. Patients who received any experimental drug in the last 30 days

2. Patients receiving spinal medication for post-operative pain relief

3. Patients who have undergone operations for complications related to inflammatory bowel disease

4. Patients with recent history of abdominal radiation therapy.

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Drug:
• IV Methylnaltrexone (MNTX)

• Placebo

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to tolerance of liquids	To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.	7 days
Secondary	Time to first bowel movement	To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.	7 days
Secondary	Time to tolerance of solid foods	To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.	7 days
Secondary	Time to first micturition post foley catheter removal	To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.	7 days
Secondary	Time to hospital discharge	To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.	7 days