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

Primary Purpose

Postoperative Ileus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IV Methylnaltrexone (MNTX)
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Progenics Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 27, 2011
Last Updated
November 26, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01367548
Brief Title
Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
Official Title
A Phase II Double-Blind Randomized Parallel Group Study of Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IV Methylnaltrexone (MNTX)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Time to tolerance of liquids
Description
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 Frame
7 days
Secondary Outcome Measure Information:
Title
Time to first bowel movement
Description
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 Frame
7 days
Title
Time to tolerance of solid foods
Description
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 Frame
7 days
Title
Time to first micturition post foley catheter removal
Description
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 Frame
7 days
Title
Time to hospital discharge
Description
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 Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females, 18 yrs or older Patients who have undergone a segmental colectomy Must be receiving opioids via IV. Exclusion Criteria: Patients who received any experimental drug in the last 30 days Patients receiving spinal medication for post-operative pain relief Patients who have undergone operations for complications related to inflammatory bowel disease Patients with recent history of abdominal radiation therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tage Ramakrishna, MD
Organizational Affiliation
Progenics Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Progenics Pharmaceuticals, Inc.
City
Tarrytown
State/Province
New York
ZIP/Postal Code
10591
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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