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Completed

NCT Number: NCT01367548

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

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.

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Key information

Conditions

Postoperative Ileus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IV Methylnaltrexone (MNTX)

Drug

Placebo

Drug

Primary outcomes

  1. Time to tolerance of liquids

    Time frame: 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 outcomes

  1. Time to first bowel movement

    Time frame: 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.

  2. Time to tolerance of solid foods

    Time frame: 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.

  3. Time to first micturition post foley catheter removal

    Time frame: 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.

  4. Time to hospital discharge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jun 7, 2011
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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