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

Phase 2

Completed

• Conditions: Postoperative Ileus
• Interventions: Drug: Placebo; Drug: IV Methylnaltrexone (MNTX)

• Registration Number: NCT01367548
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	-
Arm 1	IV Methylnaltrexone (MNTX)	-

Primary Outcome Measures

Name	Time	Method
Time to tolerance of liquids	7 days	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.

Secondary Outcome Measures

Name	Time	Method
Time to first micturition post foley catheter removal	7 days	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.
Time to hospital discharge	7 days	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.
Time to first bowel movement	7 days	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.
Time to tolerance of solid foods	7 days	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.

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States